HAND GEL SANITIZER- alcohol gel 
Allied Pressroom Products

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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Hand Gel Isopropyl Alcohol Sanitizer

This is an isopropyl alcohol based hand sanitizer manufactured following the CDC recomendation of using an alcohol concentration of more than 60 % v/v alcohol when soap and water is not available.

It is manufactured by gelling a 70 % isopropyl alcohol solution with the minimum of an acrylate polymer to create a clear gel that is easy to apply and does not evaporate as readiliy as the liquid versions to provide sufficient dwell time to be effective.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product::

  1. Alcohol (isopropyl alcohol) (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. Glycerin (1.00 % v/v)..
  3. Polypropylene Glycol (1.2 % v/v)..
  4. Acrylate Polymer (0.3% v/v).
  5. Sterile distilled water or boiled cold water.

No other materials are used.

Active Ingredient(s)

Isopropyl 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, Polypropylene Glycol, glycerin, Acrylate polymer.

Package Label - Principal Display Panel

3785 ml NDC 78851-444-05

3785 ml label946 ml NDC 78851-444-04

946 ml label240 ml NDC 78851-444-03

240 ml label120 ml MDC 78851-444-02

120 ml label105 ml NDC 78851-444-01 back 105 ml label back105 ml label front105 105 ml NDC 78851-444-01 front

HAND GEL SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78851-444
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) 1.2 mL  in 100 mL
ALLYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (LOW ALLYL METHACRYLATE) (UNII: PI80E777XB) 0.3 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78851-444-01105 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/23/2020
2NDC:78851-444-02120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/23/2020
3NDC:78851-444-03240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/23/2020
4NDC:78851-444-04946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/23/2020
5NDC:78851-444-053785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/23/2020
Labeler - Allied Pressroom Products (069895618)
Registrant - Allied Pressroom Products (069895618)
Establishment
NameAddressID/FEIBusiness Operations
Allied Pressroom Products069895618manufacture(78851-444)

Revised: 6/2020
Document Id: a8c58209-a40e-e3be-e053-2a95a90a3226
Set id: a8c57c55-829a-e3c0-e053-2a95a90a8b8e
Version: 1
Effective Time: 20200623
 
Allied Pressroom Products