Hydrating Hand Sanitizer:Gel

HYDRATING HAND SAINTIZER- ethyl alcohol gel
Natural Distributions Ltd. o/a Purple Frog Products Suite

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Ethyl Alcohol 70%

Purpose -Antiseptic Skin cleanser

Use

Antiseptic Skin cleanser

Warnings

Keep away from open flame & sources of heat.

For extenal use only.

Keep out of children

If accidently swallowed, call a posion control center or get medical help right away.

Do not get into eyes

If contact occurs, rinse thoroughly with water

Children,adolescents and adults 2 years and over.
for occasional and personal domestic use
supervise children when they use this product.
Place enough product on your plam to thoroughly cover your hands.
rub thoroughly into hands for at least 30 seconds
Allow to dry.

Other Information

May discolor certain fabrics or surfaces
do not store above 110 F ( 43 C)

Distilled Water, Vegetable Glycerin, Carbomer Polymer, Triethanolamine, Grapefruit essential oil blend, Aloe Barbadensis Leaf Juice, Vitamin E Extract, Denatonium Benzoate

HYDRATING HAND SAINTIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80382-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
WATER (UNII: 059QF0KO0R)
GRAPEFRUIT OIL (UNII: YR377U58W9)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:80382-002-95	950 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/20/2020
2	NDC:80382-002-12	125 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/20/2020
3	NDC:80382-002-60	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/20/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/20/2020

Labeler - Natural Distributions Ltd. o/a Purple Frog Products Suite (204124481)