MOISTURIZING HAND SANITIZER- isopropyl alcohol liquid 
Molecular GPS Enterprises dba Clayton Chemical

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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Moisturizing Hand Sanitizer

This is a hand sanitizer manufactured according to CFR Part333A and 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, ISO9001, and EN13485:

  1. Isopropyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (2.0% v/v).
  3. Lavender oil ((0.2% v/v).
  4. Guar Gum (0.025% wt/v).
  5. Glacial acetic acid (000% v/v)
  6. Hydrogen peroxide (0.15% v/v).
  7. Collagen (0.0003% wt/v).
  8. Purified 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)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

59 ml NDC 78548-5102-1 back label

Purpose

Antiseptic, Hand Sanitizer

3800 ml NDC 78548-5102-4

3800 ml NDC 78548-5102-4 front label

Use

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

946 ml NDC 78548-5102-3

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

glycerin, lavender oil, guar gum, glacial acetic acid, hydrogen peroxide, collagen, purified water USP

Package Label - Principal Display Panel

59 ml NDC: 78548-5102-1

946 ml NDC: 78548-5102-3

3840 ml NDC: 78548-5102-4

59 ml NDC 78548-5102-1

MOISTURIZING HAND SANITIZER 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78548-5102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL700 mL  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 20 mL  in 1000 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 4.2 mL  in 1000 mL
WATER (UNII: 059QF0KO0R) 272.45 mL  in 1000 mL
LAVENDER OIL (UNII: ZBP1YXW0H8) 2 mL  in 1000 mL
ACETIC ACID (UNII: Q40Q9N063P) 0.1 mL  in 1000 mL
BOVINE TYPE I COLLAGEN (UNII: FHJ3ATL51C) 1 mL  in 1000 mL
GUAR GUM (UNII: E89I1637KE) 0.25 mL  in 1000 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78548-5102-159 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product07/17/2020
2NDC:78548-5102-3946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/17/2020
3NDC:78548-5102-43800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/17/2020
Labeler - Molecular GPS Enterprises dba Clayton Chemical (075329532)
Registrant - Molecular GPS Enterprises dba Clayton Chemical (075329532)
Establishment
NameAddressID/FEIBusiness Operations
Molecular GPS Enterprises dba Clayton Chemical075329532manufacture(78548-5102)

Revised: 1/2022
Document Id: d5e2f6bf-7ef0-99b8-e053-2a95a90a4e67
Set id: aaacab13-1758-14cc-e053-2a95a90a3406
Version: 2
Effective Time: 20220118
 
Molecular GPS Enterprises dba Clayton Chemical