Hand Sanitizer by A. J. & W. Incorporated

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by A. J. & W. Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- ethyl alcohol gel 
A. J. & W. 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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Purpose

Antiseptic

Active Ingredient(s)

Ethyl Alcohol 75% v/v

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame. Stop use and consult a doctor if irritation or rash appears. Keep out of reach of children. If swallowed, seek immediate medical attention.

Do not use

• On children less than 2 years old.
• On open skin wounds.
• Orally.
• For other purposes other than specified.

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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.

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

Wet hands thoroughly and rub hands together until dry without wiping.

Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Water, Glycerin, Carbomer, Propylene Glycol, Aloe Barbadensis Leaf Extract, Fragrance, FD&C Green No. 3

Package Label - Principal Display Panel

60 ml NDC: 74839-105-60

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74839-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74839-105-60	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020	01/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/01/2020	01/31/2022

Labeler - A. J. & W. Incorporated (064157654)

Registrant - A. J. & W. Incorporated (064157654)

Revised: 1/2022

Document Id: e6eed3e2-77a2-f8c0-e053-2a95a90a5230

34390-5

Set id: aed71967-f718-e856-e053-2a95a90a527d

Version: 3

Effective Time: 20220131