HAND SANITIZER- 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 - Carbomer Formula

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 in the preparation of the product.

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.

  1. Glycerol (0.63% v/v).
  2. Carbomer 940 (6.27% v/v).
  3. PEG-8 Dimethicone (0.45% v/v)
  4. Trolamine (0.22% v/v)
  5. East Indian Lemon Grass Oil (0.14% v/v)
  6. Sterile distilled water or boiled cold water.

The firm does not add other active ingredients.

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

Water, Carbomer 940, Glycerin, PEG-8 Dimethicone, Trolamine, Fragrance

Package Label - Principal Display Panel

74793-0006-7

74793-0006-616.9oz Gel Tall NDC 74793-0006-58.5 oz NDC: 74793-0006-116.9 oz NDC: 74793-0006-28.5 oz NDC: 74793-0006-1

16.9 oz NDC: 74793-0006-2

1 Gallon NDC: 74793-0006-3

8.5 oz Lemon NDA 74793-0006-4

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74793-0006
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 940 (UNII: 4Q93RCW27E) 6.27 mL  in 100 mL
EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW) 0.14 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.63 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.22 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
PEG-8 DIMETHICONE (UNII: GIA7T764OD) 0.45 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74793-0006-1250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2020
2NDC:74793-0006-2500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2020
3NDC:74793-0006-33780 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2020
4NDC:74793-0006-5500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2020
5NDC:74793-0006-6479 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2020
6NDC:74793-0006-7241 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/06/2020
Labeler - Streamline Polymers LLC (117054225)
Registrant - Streamline Polymers LLC (117054225)
Establishment
NameAddressID/FEIBusiness Operations
Streamline Polymers LLC117054225manufacture(74793-0006)

Revised: 2/2021
Document Id: bad9160d-4d05-4525-e053-2995a90a5e99
Set id: aa71d621-ef78-3cbb-e053-2995a90acc4e
Version: 5
Effective Time: 20210208
 
Streamline Polymers LLC