42090), fd & c yellow 5 (ci 19140), fd & c red 33(ci 17200)
TRANSCRIPT
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AIR AND WATER HAND SANITIZER KIT- ethyl alcohol Pearl World Inc.Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if theycomply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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AIR&WATER Hand Sanitizer Kit
AIR&WATER Merry Peppermint Hand Sanitizer
Drug Facts
Active ingredientEthyl Alcohol 70%
PurposeAntiseptic
Uses
• To decrease bacteria on the skin that could cause disease. • When water, soap and towel arenot available. • Recommended for repeated use.
WarningsFor external use only: hands .Flammable. Keep away from fire or flame.When us ing this product • Keep out of eyes, ears, or mouth. • In case of eye contact, flush eyesthoroughly with water. • Avoid contact with broken skin. • Do not inhale or ingest.
Stop use and ask a doctor if • Redness or irritation develop • Condition persists for more than 72hours.
Keep out of reach of children. • Children should be supervised by an adult when using this product. •If swallowed, get medical help or contact a Poison Control Center right away.
Directions • Wet hands thoroughly with product and allow to dry without wiping. • No rinsing required.• For children under 6, use only under adult supervision. • Not recommended for infants.
Other information • Store below 105°F (40°C). • May discolor certain fabrics. • Harmful to woodfinishes & plastics.
Inactive ingredients : Water (Aqua), Triethanolamine, Carbomer, Aloe Barbadensis Leaf Extract,Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate (Vitamin E). Main Contain: FD & C Red40 (CI 16035), FD & C Yellow 6 (CI 15985), FD & C Violet 2 (CI 60725), FD & C Blue 1 (CI42090), FD & C Yellow 5 (CI 19140), FD & C Red 33(CI 17200).
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70% Alcohol
Manufactured for and distributed by Pearl world Inc, NY, NY 10019Pearlworldinc.com All rights reserved. Designed in the USA. Made in PRC.
AIR&WATER Sugar Plum Hand Sanitizer
Drug Facts
Active ingredientEthyl Alcohol 70%
PurposeAntiseptic
Uses
• To decrease bacteria on the skin that could cause disease. • When water, soap and towel are notavailable. • Recommended for repeated use.
WarningsFor external use only: hands .Flammable. Keep away from fire or flame.When us ing this product • Keep out of eyes, ears, or mouth. • In case if eye contact, flush eyesthoroughly with water. • Avoid contact with broken skin. • Do not inhale or ingest.
Stop use and ask a doctor if • Redness or irritation develop • Condition persists for more than 72hours.
Keep out of reach of children. • Children should be supervised by an adult when using this product. •if swallowed, get medical help or contact a Poison Control Center right away.
Directions • Wet hands thoroughly with product and allow to dry without wiping. • No rinsingrequired. • For children under 6, use only under adult supervision. • Not recommended for infants.
Other information • Store below 105°F (40°C). • May discolor certain fabrics. • Harmful to woodfinishes & plastics.
Inactive ingredients : Water (Aqua), Triethanolamine, Carbomer, Aloe Barbadensis Leaf Extract,Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate (Vitamin E). Main Contain: FD & C Red40 (CI 16035), FD & C Yellow 6 (CI 15985), FD & C Violet 2 (CI 60725), FD & C Blue 1 (CI 42090),FD & C Yellow 5 (CI 19140), FD & C Red 33 (CI 17200).
70% Alcohol
Manufactured for and distributed by Pearl World Inc, NY, NY 10019 Pearlworldinc.com
All rights reserved. Designed in the USA. Made in PRC.
![Page 3: 42090), FD & C Yellow 5 (CI 19140), FD & C Red 33(CI 17200)](https://reader034.vdocument.in/reader034/viewer/2022052514/628bd3b47a3e76127b72884a/html5/thumbnails/3.jpg)
AIR&WATER Snow Mint Hand Sanitizer
Drug Facts
Active ingredientEthyl Alcohol 70%
PurposeAntiseptic
Uses
• To decrease bacteria on the skin that could cause disease. • When water, soap and towel are notavailable. • Recommended for repeated use.
WarningsFor external use only: hands .Flammable. Keep away from fire or flame.When us ing this product • Keep out of eyes, ears, or mouth. • In case of eye contact, flush eyesthoroughly with water. • Avoid contact with broken skin. • Do not inhale or ingest.
Stop use and ask a doctor if • Redness or irritation develop. • Condition persists for more than 72hours.
Keep out of reach of children. • Children should be supervised by an adult when using this product. •If swallowed, get medical help or contact a Poison Control Center right away.
Directions • Wet hands thoroughly with product and allow to dry without wiping. • No rinsing required.• For children under 6, use only under adult supervision. • Not recommended for infants.
Other information • Store below 105°F (40°C) • May discolor certain fabrics. • Harmful to woodfinishes & plastics.
Inactive ingredients : Water (Aqua), Triethanolamine, Carbomer, Aloe Barbadensis Leaf Extract,Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate (Vitamin E). Main Contain: FD & C Red40 (CI 16035), FD & C Yellow 6 (CI 15985), FD & C Violet 2 (CI 60725), FD & C Blue 1 (CI 42090),FD & C Yellow 5 (CI 19140), FD & C Red 33(CI 17200).
AIR&WATER Chris tmas Berry Hand Sanitizer
Active ingredientEthyl Alcohol 70%
Purpose
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Antiseptic
Uses
• To decrease bacteria on the skin that could cause disease. • When water, soap and towel are notavailable. • Recommended for repeated use.
WarningsFor external use only: hands .Flammable. Keep away from fire or flame.When us ing this product • Keep out of eyes, ears, or mouth. • In case of eye contact, flush eyesthoroughly with water. • Avoid contact with broken skin. • Do not inhale or ingest.
Stop use and ask a doctor if • Redness or irritation develop. • Condition persists for more than 72hours.
Keep out of reach of children. • Children should be supervised by an adult when using this product. •If swallowed, get medical help or contact a Poison Control Center right away.
Directions • Wet hands thoroughly with product and allow to dry without wiping. • No rinsing required.• For children under 6, use only under adult supervision. • Not recommended for infants.
Other information • Store below 105°F (40°C). • May discolor certain fabrics. • Harmful to woodfinishes & plastics.
Inactive ingredients : Water (Aqua), Triethanolamine, Carbomer, Aloe Barbadensis Leaf Extract,Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate (Vitamin E). Main Contain: FD & C Red40 (CI 16035), FD & C Yellow 6 (CI 15985), FD & C Violet 2 (CI 60725), FD & C Blue 1 (CI 42090),FD & C Yellow 5 (CI 19140), FD & C Red 33(CI 17200).
70% Alcohol
Manufactured for and distributed by Pearl world Inc, NY, NY 10019
Pearlworldinc.com All rights reserved. Designed in the USA. Made in PRC.
Packaging
![Page 5: 42090), FD & C Yellow 5 (CI 19140), FD & C Red 33(CI 17200)](https://reader034.vdocument.in/reader034/viewer/2022052514/628bd3b47a3e76127b72884a/html5/thumbnails/5.jpg)
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AIR AND WATER HAND SANITIZER KIT ethyl alcohol kit
Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:6 9 9 33-40 4
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Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:6 9 9 33-40 4-6 0 1 in 1 KIT; Type 0 : No t a Co mbinatio n Pro duct 0 9 /18 /20 20
Quantity of PartsPart # Package Quantity Total Product QuantityPa rt 1 1 BOTTLE 6 0 mL
Pa rt 2 1 BOTTLE 6 0 mL
Pa rt 3 1 BOTTLE 6 0 mL
Pa rt 4 1 BOTTLE 6 0 mL
Part 1 of 4
AIR AND WATER HAND SANITIZER - MERRY PEPPERMINT ethyl alcohol gel
Product InformationIte m Code (Source ) NDC:6 9 9 33-40 0
Route of Adminis tration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength
ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M) ALCOHOL 70 mL in 10 0 mL
Inactive IngredientsIngredient Name Strength
WATER (UNII: 0 59 QF0 KO0 R)
TRO LAMINE (UNII: 9 O3K9 3S3TK)
CARBO MER HO MO PO LYMER, UNSPECIFIED TYPE (UNII: 0 A5MM30 7FC)
ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)
GLYCERIN (UNII: PDC6 A3C0 OX)
PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)
.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )
FD&C RED NO . 4 0 (UNII: WZB9 127XOA)
FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )
D&C VIO LET NO . 2 (UNII: 350 KA7O6 HK)
FD&C BLUE NO . 1 (UNII: H3R47K3TBD)
FD&C YELLO W NO . 5 (UNII: I753WB2F1M)
D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)
Packaging
![Page 9: 42090), FD & C Yellow 5 (CI 19140), FD & C Red 33(CI 17200)](https://reader034.vdocument.in/reader034/viewer/2022052514/628bd3b47a3e76127b72884a/html5/thumbnails/9.jpg)
# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:6 9 9 33-40 0 -6 0 6 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date
OTC mo no graph no t fina l part333A 0 9 /18 /20 20
Part 2 of 4
AIR AND WATER HAND SANITIZER - SUGAR PLUM ethyl alcohol gel
Product InformationIte m Code (Source ) NDC:6 9 9 33-40 1
Route of Adminis tration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength
ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M) ALCOHOL 70 mL in 10 0 mL
Inactive IngredientsIngredient Name Strength
WATER (UNII: 0 59 QF0 KO0 R)
TRO LAMINE (UNII: 9 O3K9 3S3TK)
CARBO MER HO MO PO LYMER, UNSPECIFIED TYPE (UNII: 0 A5MM30 7FC)
ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)
GLYCERIN (UNII: PDC6 A3C0 OX)
PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)
.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )
FD&C RED NO . 4 0 (UNII: WZB9 127XOA)
FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )
D&C VIO LET NO . 2 (UNII: 350 KA7O6 HK)
FD&C BLUE NO . 1 (UNII: H3R47K3TBD)
FD&C YELLO W NO . 5 (UNII: I753WB2F1M)
D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)
Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:6 9 9 33-40 1-6 0 6 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
![Page 10: 42090), FD & C Yellow 5 (CI 19140), FD & C Red 33(CI 17200)](https://reader034.vdocument.in/reader034/viewer/2022052514/628bd3b47a3e76127b72884a/html5/thumbnails/10.jpg)
Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date
OTC mo no graph no t fina l part333A 0 9 /18 /20 20
Part 3 of 4
AIR AND WATER HAND SANITIZER - SNOW MINT ethyl alcohol gel
Product InformationIte m Code (Source ) NDC:6 9 9 33-40 2
Route of Adminis tration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength
ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M) ALCOHOL 70 mL in 10 0 mL
Inactive IngredientsIngredient Name Strength
WATER (UNII: 0 59 QF0 KO0 R)
TRO LAMINE (UNII: 9 O3K9 3S3TK)
CARBO MER HO MO PO LYMER, UNSPECIFIED TYPE (UNII: 0 A5MM30 7FC)
ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)
GLYCERIN (UNII: PDC6 A3C0 OX)
PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)
.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )
FD&C RED NO . 4 0 (UNII: WZB9 127XOA)
FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )
D&C VIO LET NO . 2 (UNII: 350 KA7O6 HK)
FD&C BLUE NO . 1 (UNII: H3R47K3TBD)
FD&C YELLO W NO . 5 (UNII: I753WB2F1M)
D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)
Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:6 9 9 33-40 2-6 0 6 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date
OTC mo no graph no t fina l part333A 0 9 /18 /20 20
![Page 11: 42090), FD & C Yellow 5 (CI 19140), FD & C Red 33(CI 17200)](https://reader034.vdocument.in/reader034/viewer/2022052514/628bd3b47a3e76127b72884a/html5/thumbnails/11.jpg)
Part 4 of 4
AIR AND WATER HAND SANITIZER - CHRISTMAS BERRY ethyl alcohol gel
Product InformationIte m Code (Source ) NDC:6 9 9 33-40 3
Route of Adminis tration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength
ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M) ALCOHOL 70 mL in 10 0 mL
Inactive IngredientsIngredient Name Strength
WATER (UNII: 0 59 QF0 KO0 R)
TRO LAMINE (UNII: 9 O3K9 3S3TK)
CARBO MER HO MO PO LYMER, UNSPECIFIED TYPE (UNII: 0 A5MM30 7FC)
ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)
GLYCERIN (UNII: PDC6 A3C0 OX)
PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)
.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )
FD&C RED NO . 4 0 (UNII: WZB9 127XOA)
FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )
D&C VIO LET NO . 2 (UNII: 350 KA7O6 HK)
FD&C BLUE NO . 1 (UNII: H3R47K3TBD)
FD&C YELLO W NO . 5 (UNII: I753WB2F1M)
D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)
Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:6 9 9 33-40 3-6 0 6 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date
OTC mo no graph no t fina l part333A 0 9 /18 /20 20
Marketing Information
![Page 12: 42090), FD & C Yellow 5 (CI 19140), FD & C Red 33(CI 17200)](https://reader034.vdocument.in/reader034/viewer/2022052514/628bd3b47a3e76127b72884a/html5/thumbnails/12.jpg)
Pearl World Inc.
Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End DateOTC mo no graph no t fina l part333A 0 9 /18 /20 20
Labeler - Pearl World Inc. (043130142)
Revised: 9/2020