Biotipo Cleanser Antibacterial Antiseptic

Biotipo Cleanser Antibacterial Antiseptic by

Drug Labeling and Warnings

Biotipo Cleanser Antibacterial Antiseptic 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 CLEANSER ANTIBACTERIAL ANTISEPTIC- ethyl 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 Cleanser Antibacterial Antiseptic

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from fire, flame, sparks, and heat. Keep out of reach children.

Keep out of reach of children.

Do not use

In children less than 2 months of age. On open skin wounds.

When using this product

Do not inhale the vapor or grains of the product if occurs. In the case of inhaling: if you feel uncomfortable get some fresh air. In case of contact with eyes. If you are wearing contact lenses, remove than immediately. Rinse your eyes with plenty of clean water. Seek for medical advice if necessary. If swallowed, get medical help or contact Poison Control Center right away. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Stop use and ask a doctor if irritation or rash occurs.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

Store between 15-30°C (59-86°F). Avoid freezing and excessive heat above 40°C (104°F).

Inactive ingredients

Water, Glycerin.

Package Label - Principal Display Panel

Made in Brazil: Unibeleza Ind. E Com. de Cosméticos Ltda / Street Dr. Álvaro Camargo, 2611 / Santa Mônica - Belo Horizonte/MG / Zip Code: 31.565-312
Anvisa Operating License: 2.054292.2

Biotipo Cleanser Antibacterial Antiseptic (77457-014-01)

Biotipo Cleanser Antibacterial Antiseptic (77457-015-01)

BIOTIPO CLEANSER ANTIBACTERIAL ANTISEPTIC 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77457-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77457-014-01	500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/27/2020	12/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/27/2020	12/31/2020

BIOTIPO CLEANSER ANTIBACTERIAL ANTISEPTIC 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77457-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 L  in 1 L

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77457-015-01	5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/27/2020	12/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/27/2020	12/31/2020

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

Revised: 5/2021

Document Id: c2b165b4-95d1-088d-e053-2995a90acf95

34390-5

Set id: addd73d7-f845-a0bc-e053-2a95a90a5ae9

Version: 3

Effective Time: 20210519

 

Unibeleza