Alcohol Antiseptic 62% Hand Sanitizer

Alcohol by

Drug Labeling and Warnings

Alcohol by is a Otc medication manufactured, distributed, or labeled by Accupack Midwest. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALCOHOL- alcohol gel 
Accupack Midwest

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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Alcohol Antiseptic 62% Hand Sanitizer

Drug Facts

Active ingredient

Alcohol 62% v/v

Purpose

Antiseptic

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease.

Warnings

• For external use only. Flammable. Keep away from heat or flame.
• Avoid contact with eyes. If contact occurs, flush with water.

Stop use and ask a doctor

Stop use and ask a doctor if irritation or rash occurs.

Keep out of reach of children.

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

Directions

Apply small amount of product into palms. Rub product on all areas of the hand until dry.

Inactive ingredients

Water, Glycerin, Hydroxypropyl Methylcellulose, Fragrance, Tocopheryl (Vitamin E), Aloe Barbadensis Leaf Juice

Hand Sanitizer Gel

Alcohol 62%

2 fl. oz (60 ml)

Dist. by: Accupack Midwest, Inc

1060 Meta Drive, Cincinnati, OH 45237

ALCOHOL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69904-0010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)
ALOE (UNII: V5VD430YW9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69904-0010-2	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/21/2020	05/21/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/21/2020	05/21/2022

Labeler - Accupack Midwest (139637433)

Establishment
Name	Address	ID/FEI	Business Operations
Accupack Midwest		139637433	manufacture(69904-0010)

Revised: 6/2021

Document Id: c5881337-3488-5274-e053-2a95a90a863c

34390-5

Set id: a6a0bb32-cb19-3d36-e053-2995a90a3cc5

Version: 2

Effective Time: 20210624