BUFFERIN HAND SANITIZER- alcohol gel 
Genomma Lab USA

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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Bufferin® Hand Sanitizer

Drug Facts

Active Ingredient

Ethyl alcohol 70% v/v

Purpose

Antiseptic

Uses

Warnings

For external use only.

Flammable. Keep away from fire or flame.

When using this product

  • Keep out of eyes. In case of contact with eyes, rinse thoroughly with water
  • Do not use on broken or irritated skin.

Stop use and ask a doctor if irritation or redness develop and last more than 72 hours.

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, triethanolamine, fragrance, propylene glycol, glycerin, aloe barbadensis extract, tocopheryl acetate.

Questions?

Call toll free 1-877-994-3666 Monday to Friday, 8am to 6pm, Central time

Distributed by: Genomma Lab USA
Inc., Houston, TX, 77027

PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

The Science
of Healthy Hands

70% ETHYL ALCOHOL
SOURCED IN THE USA

BUFFERIN®
HAND SANITIZER

Antibacterial Gel

KILLS 99.99%
OF BACTERIA

enriched with
Vitamin E & Aloe

8 fl oz
(236 ml)

2000009663
S-20N092

Principal Display Panel - 236 ml Bottle Label
BUFFERIN HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-608
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)  
Water (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
Propylene glycol (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-608-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/12/2020
2NDC:50066-608-0270 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E08/12/2020
Labeler - Genomma Lab USA (832323534)

Revised: 9/2020
Document Id: 94158a3b-f82c-46b6-892b-b8aad7d872c1
Set id: a4522f37-af9c-4e4e-b42d-55a64bd85f5a
Version: 3
Effective Time: 20200915
 
Genomma Lab USA