HAND SANITIZER 70% GEL SOLUTION- alcohol gel 
U.S. Oil Chem, LLC

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 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. Sterile Water
  3. Hydroxypropyl Cellulose

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)

Go Clean 70% Gel Hand Sanitizer Topical Solution

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

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

purified water USP, HYDROXYPROPYL CELLULOSE

Package Label - Principal Display Panel

Principal Label

HAND SANITIZER 70% GEL SOLUTION 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74833-720
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL2649 mL  in 3783 mL
Inactive Ingredients
Ingredient NameStrength
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74833-720-03120 mL in 1 BOTTLE; Type 0: Not a Combination Product06/12/2020
2NDC:74833-720-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product06/12/2020
3NDC:74833-720-04240 mL in 1 BOTTLE; Type 0: Not a Combination Product06/12/2020
4NDC:74833-720-05475 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/12/2020
5NDC:74833-720-06950 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/12/2020
6NDC:74833-720-083786 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/12/2020
7NDC:74833-720-071893 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/12/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/12/2020
Labeler - U.S. Oil Chem, LLC (080356315)

Revised: 7/2020
Document Id: ab117ce9-cc35-ffd9-e053-2995a90adec7
Set id: a7a31ab1-5e9f-542e-e053-2995a90aeb80
Version: 8
Effective Time: 20200722
 
U.S. Oil Chem, LLC