PRO-SANITIZE- hand sanitizer liquid

Pro-Sanitize by

Drug Labeling and Warnings

Pro-Sanitize by is a Otc medication manufactured, distributed, or labeled by Clean Beauty Concepts. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

unclassified section

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:

a. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

b. Glycerol (1.45% v/v).

c. Hydrogen peroxide (0.125% v/v).

d. Sterile distilled water or boiled cold water.

e. Acrylates/C10 30 Alkyl acrylate crosspolymer(.20% v/v)

f. Aminomethyl propanol (.085% v/v)

active ingredient

Alcohol 70% v/v. Purpose: Antiseptic

use

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

warning

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 section

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 section

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

keep out of reach

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, acrylates/C10 30 alkyl acrylate crosspolymer, aminomethyl propanol, hydrogen peroxide

Purpose

Antiseptic

packaging

60 ML NDC: 76665-001-02

170 ML NDC: 76665-001-06

236 ML NDC: 76665-001-08

3785 ML NDC: 76665-001-01

INGREDIENTS AND APPEARANCE

PRO-SANITIZE 
hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76665-001
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
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.085 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	28.14 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)	0.2 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76665-001-02	60 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/22/2020
2	NDC: 76665-001-06	178 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/22/2020
3	NDC: 76665-001-08	236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/22/2020
4	NDC: 76665-001-01	3785 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/22/2020

Labeler - Clean Beauty Concepts (117491649)

Establishment
Name	Address	ID/FEI	Business Operations
Clean Beauty Concepts		117491649	manufacture(76665-001)