MAIN LABEL

ETHYL RUBBING ALCOHOL - alcohol liquid
COMERCIALIZADORA JIQUILPAN 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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MAIN LABEL

CONTAINS:70% Ethyl Alcohol by volume

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INDICATIONS. To decrease germs in minor cuts and scrapes

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DIRECTIONS. Apply to skin directly or with clean gauze cotton or swab For rubbing apply liberally and rub with hands.

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WARNINGS.FOR EXTERNAL USE ONLY Will produce serious gastric disturbances if taken internally

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KEEP OUT OF THE REACH OF CHILDREN. In case of accidental ingestion seek professional assistance or contact a Poison Control Center inmediately

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CAUTION Do not apply to irritated skin use in eyes or on mucous membranes incase of deep or puncture wounds consult a doctor

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INACTIVE INGREDIENTS .Denatonium Benzoate water

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LABEL label. jpg

ETHYL RUBBING ALCOHOL
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:15231-100
Route of Administration	CUTANEOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)	29.65 mL in 100 mL
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)	.35 mg in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:15231-100-01	500 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	02/09/1998

Labeler - COMERCIALIZADORA JIQUILPAN S.A. DE C.V. (589780068)

Name	Address	ID/FEI	Business Operations
Establishment
COMERCIALIZADORA JIQUILPAN S.A. DE C.V.		589780068	manufacture