HAPP HAND SANITIZER- alcohol gel
Fujian Happiness Biotech Technology Co., Ltd.

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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Active Ingredient

Ethyl Alcohol 65% v/v.

Purpose

Antiseptic

Uses

to decrease bacteria on the skin that could cause disease
recommended for repeated use

Warnings

For external use only - hands

Flammable, keep away from heat and flame

When using the product

keep out of eyes, in case of contact with eyes, flush thoroughly with water
avoid contact with broken skin
do not inhale or ingest

Stop use and ask a doctor if skin irritation develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hand thoroughly and allow to dry without wiping
For children under 6, use only under adult supervision
not recommended for infants

Inactive ingredients

Purified water, Glycerin, Polyacrylic acid, Aminomethylpropanol

Product Label

image description

HAPP HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76735-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76735-001-01	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/26/2020
2	NDC:76735-001-02	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/26/2020
3	NDC:76735-001-03	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/26/2020
4	NDC:76735-001-04	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/26/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/26/2020

Labeler - Fujian Happiness Biotech Technology Co., Ltd. (527275979)