Hand Sanitizer by MIDLAB INCORPORATED

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by MIDLAB INCORPORATED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- ethyl alcohol gel 
MIDLAB INCORPORATED

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 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70542-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 L  in 100 L

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)

Product Characteristics
Color	white (Clear, Colorless)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70542-102-41	3.78 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2020	06/28/2021

Labeler - MIDLAB INCORPORATED (047371463)

Registrant - MIDLAB INCORPORATED (047371463)

Establishment
Name	Address	ID/FEI	Business Operations
MIDLAB INCORPORATED		047371463	manufacture(70542-102)

Revised: 6/2021

Document Id: c5d3ab35-b57a-a746-e053-2a95a90a69cf

34390-5

Set id: a70cfd00-3561-18db-e053-2a95a90ac8b0

Version: 3

Effective Time: 20210628