HAND SANITIZER ALCOHOL ANTISEPTIC 70% TOPICAL GEL - MV- alcohol gel 
Solugen Blending 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.

----------

Hand Sanitizer Alcohol Antiseptic 70% Topical Gel - MV

Hand Sanitizer Alcohol Antiseptic 70% Topical Gel - MV

This is a hand sanitizer manufactured according to the part333A of the OTC monograph.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentag
formulation)
a. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v) in an aqueos solution denatured according to Alcohol and Tobacco
Bureau regulations in 27 CFR part 20.
b. Glycerol (1.25% v/v).
c. Hydroxymethyl Cellulose (1.05% v/v) .
d. Sterile distilled water or boiled cold water.

Active Ingredient(s)

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

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, methylcellulose, purified water USP

Hand Sanitizer Alcohol Antiseptic 70% Topical Gel - MV

18927000 ml label NDC 79975-005-0118927000 mL NDC: 79975-005-01

HAND SANITIZER ALCOHOL ANTISEPTIC 70% TOPICAL GEL - MV 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79975-005
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
HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1) 1.05 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.25 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79975-005-0118927000 mL in 1 TANK; Type 0: Not a Combination Product08/31/2020
2NDC:79975-005-021249000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product08/31/2020
3NDC:79975-005-03208198 mL in 1 DRUM; Type 0: Not a Combination Product08/31/2020
4NDC:79975-005-0418927 mL in 1 DRUM; Type 0: Not a Combination Product08/31/2020
5NDC:79975-005-053785 mL in 1 PAIL; Type 0: Not a Combination Product08/31/2020
6NDC:79975-005-091000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/31/2020
Labeler - Solugen Blending LLC (117590261)
Establishment
NameAddressID/FEIBusiness Operations
Solugen Blending LLC117590261manufacture(79975-005)
Establishment
NameAddressID/FEIBusiness Operations
Solugen Blending LLC117605218manufacture(79975-005)

Revised: 8/2020
Document Id: ae7422ba-e0b8-7cab-e053-2995a90a9ac7
Set id: ae74249e-ca94-7fa4-e053-2995a90a77f0
Version: 1
Effective Time: 20200831
 
Solugen Blending LLC