GENERIC HAND SANITIZER- alcohol solution 
Frozen Wheels,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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HAND SANITIZER

Drug facts

Active ingredient

Alcohol 75% v/v

Purpose

Antiseptic

Use[s]

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.

Directions

Other information

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

75% ALCOHOL ANTISEPTIC

Topical Solution

Non-sterile Solution

NO ANIMAL TESTING    

parabens FREE

Made in México.

Imported & distributed by:

Frozen Wheels, LLC

16565 NW 15th Ave.

Miami, FL 33169

QUESTIONS

786-265-1879

NOT INTENDED FOR RETAIL SALE

Packaging

image

GENERIC HAND SANITIZER 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77031-808
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77031-808-16500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/06/2020
Labeler - Frozen Wheels,Llc (069055731)

Revised: 5/2020
Document Id: e85f1334-10b6-4bd3-9cb2-255522cc7faa
Set id: 0bc05dc9-4cf3-4352-997d-e318ced9c067
Version: 1
Effective Time: 20200511
 
Frozen Wheels,Llc