Biotipo Pharma Medical BioClear 70% Isopropyl Alcohol

Biotipo Pharma Medical BioClear 70% Isopropyl Alcohol by

Drug Labeling and Warnings

Biotipo Pharma Medical BioClear 70% Isopropyl Alcohol by is a Otc medication manufactured, distributed, or labeled by Unibeleza Industria e Comercio de Cosmeticos Ltda. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BIOTIPO PHARMA MEDICAL BIOCLEAR 70% ISOPROPYL ALCOHOL- isopropyl alcohol liquid 
Unibeleza Industria e Comercio de Cosmeticos Ltda

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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Biotipo Pharma Medical BioClear 70% Isopropyl Alcohol

Active ingredient

Isopropyl alcohol 70% v/v

Purpose

First aid antiseptic

Uses

Biotipo Pharma Medical Bioclear 70% Isopropyl Alcohol first aid to help prevent the risk of infection in:

• minor cuts
• scrapes
• burns

Warnings

For external use only.

Flammable

Keep away from fire or flame, heat, spark electrical

Ask a doctor before use

for deep or puncutre wounds, animal bites or serious burns

When using this product

• do not get into eyes
• do not apply over large areas of the body
• do not use longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

if condition persists or gets worse

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

For Rubbing and Massaging

Caution - Do not apply to irritated skin or if excessive irritation develops. Avoid getting into the eyes or on mucous membranes.

Directions

• clean the affected area
• apply a small amount of this product on the area 1 to 3 times daily
• may be covered with a sterile bandage
• if bandaged, let dry first

Other Information

• does not contain, nor is intended as a substitute for grain or ethyl alcohol
• will produce serious gastric distrubances if taken internally

Inactive Ingredient

water, glycerin, Methyl salicylate

Made by

Made by: Unibeleza Industria e Comercio de Cosmeticos Ltda

Street: Dr. Alvaro Camargos, 2611/ Santa Monica-Belo Horizonte/MG - Brazil - Zip Code: 31.565-312

Anvisa Operating License: 2.054292.2

Label 1L

Label 5L

BIOTIPO PHARMA MEDICAL BIOCLEAR 70% ISOPROPYL ALCOHOL 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77457-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	700 mL  in 1 L

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
METHYL SALICYLATE (UNII: LAV5U5022Y)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77457-004-01	1 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/09/2020	12/31/2020
2	NDC: 77457-004-02	5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/09/2020	12/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/09/2020	12/31/2020

Labeler - Unibeleza Industria e Comercio de Cosmeticos Ltda (679072947)

Revised: 5/2021

Document Id: c2b1ee99-a3eb-5cdc-e053-2a95a90a2ebd

34390-5

Set id: aa0cfed2-bf24-36bf-e053-2a95a90a7694

Version: 3

Effective Time: 20210519

 

Unibeleza