HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Corporativo Industrial Bioclean, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethyl alcohol 75% v/v

PURPOSE

Antiseptic

INDICATIONS & USAGE

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

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, 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.

DOSAGE & ADMINISTRATION

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

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

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

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

QUESTIONS

Questions? Call +52-331-593-0253

PRINCIPAL DISPLAY PANEL

WAB GEL 2L NDC: 78100-300-10

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78100-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	750 mL  in 1 L

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78100-300-10	2 L in 1 BOTTLE; Type 0: Not a Combination Product	09/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/21/2020

Labeler - Corporativo Industrial Bioclean, S.A. de C.V. (951577747)

Registrant - Corporativo Industrial Bioclean, S.A. de C.V. (951577747)

Establishment
Name	Address	ID/FEI	Business Operations
Corporativo Industrial Bioclean, S.A. de C.V.		951577747	manufacture(78100-300) , label(78100-300) , pack(78100-300)