HAND SANITIZING GEL- alcohol gel

Hand Sanitizing Gel by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

The hand sanitizer is manufactured in accordance with the recommendations in 21 CFR Part 333 for alcohol based topical antimicrobial OTC products for human use.

1. Alcohol(Ethanol) 62% (v/v).
2. Sorbitol 0.6% (v/v).
3. Gylcerin 0.6% (v/v).
4. PEG-27 copolymer 0.375% (v/v)
5. Triethanol 0.7% (v/v)
6. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 80% 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

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

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

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.

Other information

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

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

203000 mL NDC: 75009-162-01

868300 mL NDC: 75009-162-02

INGREDIENTS AND APPEARANCE

HAND SANITIZING GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75009-162
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
TROLAMINE (UNII: 9O3K93S3TK)	0.7 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.6 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
ACRYLIC ACID/ISOPHORONE DIISOCYANATE/PEG-27 COPOLYMER (UNII: R0R8I3X29J)	0.375 mL  in 100 mL
SORBITOL SOLUTION (UNII: 8KW3E207O2)	0.6 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75009-162-01	203000 mL in 1 DRUM; Type 0: Not a Combination Product	03/30/2020
2	NDC: 75009-162-02	868300 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

Labeler - Alpha Aromatics (041723545)

Establishment
Name	Address	ID/FEI	Business Operations
Alpha Aromatics		041723545	manufacture(75009-162)