HAND SANITIZER- alcohol gel 
Corporativo Industrial Bioclean, 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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Ethyl alcohol 75% v/v

Antiseptic

Hand Sanitizer to help reduce bacteria that potentially can cause disease. Recommended for repeated use.

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, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

Stop use and ask a doctor if irritation or rash occurs. Condition persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Wet hands thoroughly with product and rub into skin until dry.

Children under 6 years of age should be supervised when using this product.

Avoid freezing and excessive heat above 40C (104F). May discolor some fabrics. Harmful to wood finishes and plastics.

Water, Triethanolamine, Glycerine, Carbomer and Methylchloroisothiazolinone/Methylisothiazolinone Mixture

Questions? Call +52-331-593-0253

WAB GEL 2L NDC: 78100-300-10

WAB 2L

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78100-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL750 mL  in 1 L
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX) 2 mL  in 1 L
CARBOMER 980 (UNII: 4Q93RCW27E) 3 mL  in 1 L
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W) 0.4 mL  in 1 L
TROLAMINE (UNII: 9O3K93S3TK) 2 mL  in 1 L
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78100-300-102 L in 1 BOTTLE; Type 0: Not a Combination Product09/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/21/2020
Labeler - Corporativo Industrial Bioclean, S.A. de C.V. (951577747)
Registrant - Corporativo Industrial Bioclean, S.A. de C.V. (951577747)
Establishment
NameAddressID/FEIBusiness Operations
Corporativo Industrial Bioclean, S.A. de C.V.951577747manufacture(78100-300) , label(78100-300) , pack(78100-300)

Revised: 7/2021
Document Id: c7443575-9c93-b9c6-e053-2995a90a5760
Set id: b029058b-b193-287d-e053-2995a90a1baa
Version: 2
Effective Time: 20210716
 
Corporativo Industrial Bioclean, S.A. de C.V.