62% ALCOHOL HAND SANITIZER- hand sanitizer gel

62% alcohol hand sanitizer by

Drug Labeling and Warnings

62% alcohol hand sanitizer by is a Otc medication manufactured, distributed, or labeled by Ultra Distributors Inc, Ultra Distributors, Ningbo Home Solution Corp., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Disinfection
Sterilization
No Rinseing

ACTIVE INGREDIENT

Alcohol62%

INDICATIONS & USAGE

Directions: Pour a sufficient amount of the liquid into the palm of your dry hands. Rub thoroughly all over hands briskly until dry. Repeat if necessary. Use without water. Use only under adult supervision.

KEEP OUT OF REACH OF CHILDREN

WARNINGS

Warnings: Highly flammable liquid and vapour. Causes serious eye iritation. May cause skin iritation. Keep away from heat, sparks, hot surfaces, fire, open flame and sources of ignition. No smoking. Keep at room temperature. Store in a well-ventilated, cool and dry place, away from direct sunlight. Do not store above 40 °C

For external use only.

Avoid contact with eyes. If in eyes, rinse immediately with clean water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Do not swallow. If swallowed, rinse mouth and seek medical advice immediately and show this label. Do not induce vomiting. Do not use on damage, inflamed or broken skin. If iritation or redness develops, discontinue use.

Keep out of the reach of babies, children & animals.

DOSAGE & ADMINISTRATION

236ml store in ventilated shade and Do not store above 40 °C

INACTIVE INGREDIENT

Alcohol, water/eau/aqua, carbomer，triethanolamine, propylene glycol, glycerin

Front Panel and Back Panel Art

INGREDIENTS AND APPEARANCE

62% ALCOHOL HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78495-015
Route of Administration	EXTRACORPOREAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	146.32 mL  in 236 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78495-015-01	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/07/2020

Labeler - Ultra Distributors Inc (007160073)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Distributors		007160073	relabel(78495-015)

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Home Solution Corp., LTD		679868836	manufacture(78495-015)