GEL HAND SANITIZER - METHYLCELLULOSE FORMULA- alcohol gel 
Streamline Polymers 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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Gel Hand Sanitizer Methylcellulose

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

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 (3.0% v/v).
  3. Methylcellulose (1.0% v/v)
  4. Sterile distilled water or boiled cold 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)

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

Package Label - Principal Display Panel

3780 mL NDC: Streamline Gel HS Gallon Methycellulose74793-0004-1

GEL HAND SANITIZER - METHYLCELLULOSE FORMULA 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74793-0004
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
GLYCERIN (UNII: PDC6A3C0OX) 3 mL  in 100 mL
METHYLCELLULOSE (100 CPS) (UNII: 4GFU244C4J) 1.06 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74793-0004-13780 mL in 1 JUG; Type 0: Not a Combination Product06/12/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/12/2020
Labeler - Streamline Polymers LLC (117054225)
Establishment
NameAddressID/FEIBusiness Operations
Streamline Polymers LLC117054225manufacture(74793-0004)

Revised: 1/2022
Document Id: d57b25ae-b81c-53de-e053-2a95a90aa24b
Set id: a7d34bd5-c468-1969-e053-2995a90a3828
Version: 2
Effective Time: 20220113
 
Streamline Polymers LLC