Hand Sanitizing Gel 70%(v/v) ETOH

Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

HAND SANITIZER- alcohol gel 
Alpha Aromatics

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 Sanitizing Gel 70%(v/v) ETOH

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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

Do not use

• in children less than 2 months of age
• on open skin wounds

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

• Place a dime sized amount in hands. Rub hands together until dry.
• 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

purified USP water, PEG-27 copolymer, sorbitol, glycerine, triethanolamine

Package Label - Principal Display Panel

1 quart NDC: 75009-171-01

1 gallon NDC: 75009-171-02

5 gallon NDC: 75009-171-03

55 gallon NDC: 75009-171-04

275 gallon NDC: 75009-171-05

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75009-171
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	0.6 mL  in 100 mL
SORBITOL SOLUTION (UNII: 8KW3E207O2)	0.6 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
ACRYLIC ACID/ISOPHORONE DIISOCYANATE/PEG-27 COPOLYMER (UNII: R0R8I3X29J)	0.375 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.7 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75009-171-01	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 75009-171-02	3780 mL in 1 JUG; Type 0: Not a Combination Product	03/30/2020
3	NDC: 75009-171-03	18920 mL in 1 PAIL; Type 0: Not a Combination Product	03/30/2020
4	NDC: 75009-171-04	208190 mL in 1 DRUM; Type 0: Not a Combination Product	03/30/2020
5	NDC: 75009-171-05	1040980 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020	01/01/2022

Labeler - Alpha Aromatics (041723545)

Establishment
Name	Address	ID/FEI	Business Operations
Alpha Aromatics		041723545	manufacture(75009-171)

Revised: 11/2022

Document Id: ee894a7f-bab9-4c8a-e053-2a95a90a323b

34390-5

Set id: ac897e7b-8ded-146f-e053-2995a90a107b

Version: 3

Effective Time: 20221128