PRO-SANITIZE- hand sanitizer liquid 
Clean Beauty Concepts

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

  1. 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.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.
  5. Acrylates/C10 30 Alkyl acrylate crosspolymer(.20% v/v)
  6. Aminomethyl propanol (.085% v/v)
  7. Fragrance (Parfum) (.50% v/v)

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

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

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

Other information

Inactive ingredients

water(aqua), glycerin, acrylates/C10 30 alkyl acrylate crosspolymer, aminomethyl propanol, hydrogen peroxide, fragrance(parfum).

Package Label - Principal Display Panel

473 mL NDC: 76665-002-16

16oz

60 mL NDC: 76665-002-02 60 ML NDC:76665-002-02

170 mL NDC: 76665-002-06 170 mL NDC:76665-002-06

236 mL NDC: 76665-002-08 236 mL NDC: 76665-002-08

3785 ML NDC: 76665-002-01

3785 ML NDC: 76665-002-01

PRO-SANITIZE 
hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76665-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) 0.2 mL  in 100 mL
EUCALYPTUS OIL (UNII: 2R04ONI662) 0.5 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 27.64 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.085 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76665-002-06178 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/22/2020
2NDC:76665-002-0260 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/22/2020
3NDC:76665-002-08236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/22/2020
4NDC:76665-002-013785 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/22/2020
5NDC:76665-002-16473 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product05/14/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/22/2020
Labeler - Clean Beauty Concepts (117491649)
Establishment
NameAddressID/FEIBusiness Operations
Clean Beauty Concepts117491649manufacture(76665-002)

Revised: 5/2020
Document Id: a5a3a26f-fa46-272d-e053-2a95a90a1685
Set id: a44fa866-b18e-3373-e053-2a95a90a6344
Version: 2
Effective Time: 20200514
 
Clean Beauty Concepts