FORMOCLEAN GEL HAND SANITIZER- alcohol gel

FormoClean Gel Hand Sanitizer by

Drug Labeling and Warnings

FormoClean Gel Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Applichem, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. 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)

Medicinal ingredient: Ethyl 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

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

Water (Aqua), Glycerin, Hydrogen Peroxide, Alkyl Acrylate Crosspolymer, Triethanolamine, Aloe, Lauryl Alcohol, Myristyl Alcohol, Fragrance (Parfum), PEG Dimethicone

Package Label - Principal Display Panel

3.8 L NDC: 74751-003-01

19 L NDC: 74751-003-05

189 L NDC: 74751-003-50

250 mL NDC: 74751-003-08

500 mL NDC: 74751-003-16

INGREDIENTS AND APPEARANCE

FORMOCLEAN GEL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74751-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70.6586 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.3344 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.1258 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)	0.6023 mL  in 100 mL
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)	7.6152 mL  in 100 mL
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)	0.0216 mL  in 100 mL
MYRISTYL LACTATE (UNII: 1D822OC34X)	0.2656 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.2665 mL  in 100 mL
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)	0.0187 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74751-004-01	3800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
2	NDC: 74751-004-05	19000 mL in 1 PAIL; Type 0: Not a Combination Product	03/30/2020
3	NDC: 74751-004-50	190000 mL in 1 DRUM; Type 0: Not a Combination Product	03/30/2020
4	NDC: 74751-004-08	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
5	NDC: 74751-004-16	500 mL in 1 BOTTLE, PLASTIC; 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 - Applichem, Inc (039829528)