Hand Sanitizer 70% Alcohol

Hand Sanitizer 70% Alcohol by

Drug Labeling and Warnings

Hand Sanitizer 70% Alcohol by is a Otc medication manufactured, distributed, or labeled by SurelyWell, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER 70% ALCOHOL- alcohol gel 
SurelyWell, Inc.

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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Hand Sanitizer 70% Alcohol

Drug Fact:

Active Ingredient

Ethyl Alcohol 70%

Purpose

Antimicrobial

Uses:

Helps reduce bacteria on the skin that could cause diseases.

Warnings:

Flammable. Keep away from fire or flame. For external use only.

When using this product

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

if irritation or rash aapears and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

Directions:

Place enough product in the palm of your hands to thoroughly cover you hands. Rub hands together briskly until product is completely absorbed and hands are dry.

Inactive Ingredients:

Water, Glycerin, Carbomer, Aminomethyl Propanol, Fragrance

Package Labeling:

HAND SANITIZER 70% ALCOHOL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90094-073
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 90094-073-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2020	08/10/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/01/2020	08/10/2021

Labeler - SurelyWell, Inc. (117469094)

Revised: 8/2021

Document Id: ca6367fc-d8de-1573-e053-2a95a90a4cf7

34390-5

Set id: adf42774-28ee-32af-e053-2995a90ac568

Version: 2

Effective Time: 20210825