KEEP SAFE - Rubbing alcohol 70%

Rubbing alcohol by

Drug Labeling and Warnings

Rubbing alcohol by is a Otc medication manufactured, distributed, or labeled by Desmoldantes y Aditivos, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RUBBING ALCOHOL- alcohol liquid 
Desmoldantes y Aditivos, 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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KEEP SAFE - Rubbing alcohol 70%

Active Ingredient(s)

Isopropyl alcohol 70% v/v

Purpose

Purpose: First Aid Antiseptic

Use

Firs aid to help prevent the risk of infection in minor cuts, scrapes and burns.

Warnings

For external use only.

• Flammable. Keep away from heat or flame
• If taken internally serious gastric disturbances will result.

Ask a doctor before use if you have

deep or puncture wounds, animal bites or serious burns.

When using this product

When using this product do not get into eyes, do not apply over large areas of the body, do not use longer than one week unless directed by a doctor.

Stop use and ask a doctor

if conditions persists or gets worse.

Keep out of reach of children

In case of ingestion, get meical help or call Poison Control Center inmediately.

Directions

• Clean affected area
• Apply small amount of this product on the area 1-3 times dialy.
• If bandaged, lets dry first may be covered with a sterile bandage.

Other information

• Store at room temperature
• Dos not contain, 'nor is intended as sustitute for grain or ethyl alcohol.

Inactive ingredients

Distilled water

Package Label - KEEP SAFE

975.90 ml NDC: 77357-273-01

RUBBING ALCOHOL 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77357-273
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	30 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77357-273-01	975.9 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/28/2020	06/29/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/28/2020	06/29/2021

Labeler - Desmoldantes y Aditivos, S.A. de C.V. (812364628)

Registrant - Desmoldantes y Aditivos, S.A. de C.V. (812364628)

Establishment
Name	Address	ID/FEI	Business Operations
Desmoldantes y Aditivos, S.A. de C.V.		812364628	manufacture(77357-273)

Revised: 6/2021

Document Id: c5ee4a97-ffdc-7767-e053-2a95a90a9461

34390-5

Set id: b47e5dde-f451-32d2-e053-2a95a90a6a50

Version: 5

Effective Time: 20210629