GELCOHOL 125 ML- alcohol gel 
Fulfilment, S.A. de C.V.

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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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, water, carbomer,alcohol, triethanolamine

Package Label - Principal Display Panel

125 mL NDC: 77483-126-01

BackFront

GELCOHOL 125 ML 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77483-126
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL87.5 mL  in 125 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER 934 (UNII: Z135WT9208)  
WATER (UNII: 059QF0KO0R)  
TRIETHANOLAMINE HYDRIODIDE (UNII: DT98IT03JK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77483-126-01125 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Fulfilment, S.A. de C.V. (815113642)
Registrant - Fulfilment, S.A. de C.V. (815113642)
Establishment
NameAddressID/FEIBusiness Operations
Fulfilment, S.A. de C.V.815113642manufacture(77483-126)

Revised: 5/2020
Document Id: a57f612b-7b63-331a-e053-2995a90a5749
Set id: a57f66cb-7641-52bb-e053-2995a90a5eca
Version: 1
Effective Time: 20200512
 
Fulfilment, S.A. de C.V.