HAND SANITIZER- alcohol gel
JOSE LOPEZ

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 GEL

Active Ingredient(s)

Alcohol 70%

Purpose

Antimicrobial, Hand Sanitizer

Use

For hand washing to decrease bacteria on skin

Warnings

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

Do not use

Stop use and ask a doctor if skin irritation develops

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Inactive ingredients

glycerin, water, carbomer

Package Label - Principal Display Panel

Front 11000 mL NDC: 76947-199-28

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76947-199
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
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 1342 (UNII: 809Y72KV36)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76947-199-28	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2020

Labeler - JOSE LOPEZ (049599544)

Registrant - SNS Distribution LLC (117537695)

Name	Address	ID/FEI	Business Operations
Establishment
SNS Distribution LLC		049599544	manufacture(76947-199)