Biotipo Antibacterial Liquid Hand Soap

Biotipo Antibacterial Handwashing by

Drug Labeling and Warnings

Biotipo Antibacterial Handwashing 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 ANTIBACTERIAL HANDWASHING- liquid hand soap peach solution 
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 Antibacterial Liquid Hand Soap

Description

The Biotipo Antibacterial Liquid Hand Soap has a unique formula.
GENTLE AND MOISTURIZING: Moisturizing as it cleans, this soothing liquid keeps even hard-working hands soft as well as delightfully scented. PROTECT AGAINST BACTERIA: Benzalkonium Chloride kills 99.9 percent of bacteria (bacteria encountered in household settings and public). TOUGH BUT GENTLE: Cleansing and conditioning blend together beautifully, in handwashing that's mild for the whole family. FOR THE FAMILY: Cleaning your hands with Biotipo, you are caring for your family. Formulated to be soft on the skin, even on the smaller hands.

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.14%

Purpose

Antibacterial

Uses

For handwashing to decreases bacteria on the skin.

Warnings

For external use only.

When Using this Product

Avoid Contact with eyes. In case of eye contact, flush with water.

Stop use and ask doctor if

Irritation or redness develops

Keep out of reach of children.

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

Directions

Pump ion hands, wet as needed lather vigorously for at least 15 seconds.

Wash skin, rinse thoroughly and dry.

Inactive Ingredients

Citrus Lemon

Aqua, Lauramidopropylamine Oxide, Glycerin, Cetrimonium Chloride, Lauramine Oxide, Sodium Chloride, PEG 120 Methyl Glucose Dioleate, Citric Acid, Sodium Benzoate, Parfum, Myristamidopropylamine Oxide, Zinc Sulfate, Dimethyl Lauramine, Tetrasodium EDTA, Alcohol, Dimethyl Myristamine, Citrus Sinensis Fruit Extract, Yellow 5, Tea Tree Oil, Chlorhexidine Digluconate Solution;

Galician Lime

Aqua, Lauramidopropylamine Oxide, Glycerin, Cetrimonium Chloride, Lauramine Oxide, Sodium Chloride, PEG 120 Methyl Glucose Dioleate, Citric Acid, Sodium Benzoate, Parfum, Myristamidopropylamine Oxide, Zinc Sulfate, Dimethyl Lauramine, Tetrasodium EDTA, Alcohol, Dimethyl Myristamine, Aloe Barbadensis Leaf Extract, Citrus Lemon Fruit Extract, Tea Tree Oil, Chlorhexidine Digluconate Solution;

Coconut

Aqua, Lauramidopropylamine Oxide, Glycerin, Cetrimonium Chloride, Lauramine Oxide, Sodium Chloride, PEG 120 Methyl Glucose Dioleate, Citric Acid, Sodium Benzoate, Parfum, Myristamidopropylamine Oxide, Zinc Sulfate, Dimethyl Lauramine, Tetrasodium EDTA, Alcohol, Dimethyl Myristamine, Ricinus Communis (Castor) Seed Oil, Hydrogenated Jojoba Oil, Tea Tree Oil, Coconut Oil, Chlorhexidine Digluconate Solution;

Lavender

Aqua, Lauramidopropylamine Oxide, Glycerin, Cetrimonium Chloride, Lauramine Oxide, Sodium Chloride, PEG 120 Methyl Glucose Dioleate, Citric Acid, Sodium Benzoate, Parfum, Myristamidopropylamine Oxide, Zinc Sulfate, Dimethyl Lauramine, Tetrasodium EDTA, Alcohol, Dimethyl Myristamine, Lavandula Angustifolia (Lavender) Oil, Poloxamer 125, Ext. Violet 2, Rosmarinus Officinalis Extract, Tea Tree Oil, Chlorhexidine Digluconate Solution;

Peach

Aqua, Lauramidopropylamine Oxide, Glycerin, Cetrimonium Chloride, Lauramine Oxide, Sodium Chloride, PEG 120 Methyl Glucose Dioleate, Citric Acid, Sodium Benzoate, Parfum, Myristamidopropylamine Oxide, Zinc Sulfate, Dimethyl Lauramine, Tetrasodium EDTA, Alcohol, Dimethyl Myristamine, Prunus Amygdalus Dulcis (Sweet Almond) Seed Extract, DC red no. 33, Tea Tree Oil, Chlorhexidine Digluconate Solution;

Customer Service

1 617-710-8020

Legal Entity

biotipobrazil.com

info@biotipobrazil.com

Made by: Unibeleza Ind. E Com. de Cosméticos Ltda /

Street: Dr. Álvaro Camargos, 2611 / Santa Mônica - Belo Horizonte/MG

Brasil - ZIP CODE 31.565-312
Anvisa Operating License2.054292.2

^Encountered in household settings

#Antibacterial Hand Soap

Topical Liquid

Liquid Hand Soap

Front and the back of the pack

BIOTIPO ANTIBACTERIAL HANDWASHING 
liquid hand soap peach solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77457-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.14 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PRUNUS PERSICA FRUITING TOP (UNII: U08429QT99)
MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)
ZINC SULFATE HEPTAHYDRATE (UNII: N57JI2K7WP)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
GLYCERIN (UNII: PDC6A3C0OX)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM BENZOATE (UNII: OJ245FE5EU)
EDETATE SODIUM (UNII: MP1J8420LU)
DIMETHYL MYRISTAMINE (UNII: 5E4O85D8T2)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
TEA TREE OIL (UNII: VIF565UC2G)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
DIMETHYL LAURAMINE (UNII: 6V2OM30I1Z)
ALMOND OIL (UNII: 66YXD4DKO9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77457-005-01	500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/28/2020	08/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/28/2020	08/31/2023

BIOTIPO ANTIBACTERIAL HANDWASHING 
liquid hand soap lavender solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77457-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.14 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PEG/PPG-125/30 COPOLYMER (UNII: ETS9O8IMRZ)
MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)
ZINC SULFATE HEPTAHYDRATE (UNII: N57JI2K7WP)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
GLYCERIN (UNII: PDC6A3C0OX)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM BENZOATE (UNII: OJ245FE5EU)
EDETATE SODIUM (UNII: MP1J8420LU)
DIMETHYL MYRISTAMINE (UNII: 5E4O85D8T2)
WATER (UNII: 059QF0KO0R)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
TEA TREE OIL (UNII: VIF565UC2G)
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)
DIMETHYL LAURAMINE (UNII: 6V2OM30I1Z)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ALCOHOL (UNII: 3K9958V90M)
ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77457-007-01	500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/28/2020	08/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/28/2020	08/31/2023

BIOTIPO ANTIBACTERIAL HANDWASHING 
liquid hand soap galician lime solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77457-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.14 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)
ZINC SULFATE HEPTAHYDRATE (UNII: N57JI2K7WP)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
GLYCERIN (UNII: PDC6A3C0OX)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM BENZOATE (UNII: OJ245FE5EU)
EDETATE SODIUM (UNII: MP1J8420LU)
DIMETHYL MYRISTAMINE (UNII: 5E4O85D8T2)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
TEA TREE OIL (UNII: VIF565UC2G)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIMETHYL LAURAMINE (UNII: 6V2OM30I1Z)
LIME (CITRUS) (UNII: 8CZS546954)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77457-008-01	500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/28/2020	08/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/28/2020	08/31/2023

BIOTIPO ANTIBACTERIAL HANDWASHING 
liquid hand soap coconut solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77457-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.14 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)
ZINC SULFATE HEPTAHYDRATE (UNII: N57JI2K7WP)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
GLYCERIN (UNII: PDC6A3C0OX)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM BENZOATE (UNII: OJ245FE5EU)
EDETATE SODIUM (UNII: MP1J8420LU)
DIMETHYL MYRISTAMINE (UNII: 5E4O85D8T2)
WATER (UNII: 059QF0KO0R)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
TEA TREE OIL (UNII: VIF565UC2G)
DIMETHYL LAURAMINE (UNII: 6V2OM30I1Z)
ALCOHOL (UNII: 3K9958V90M)
COCONUT OIL (UNII: Q9L0O73W7L)
JOJOBA OIL (UNII: 724GKU717M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77457-009-01	500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/28/2020	08/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/28/2020	08/31/2023

BIOTIPO ANTIBACTERIAL HANDWASHING 
liquid hand soap citrus lemon solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77457-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.14 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)
ZINC SULFATE HEPTAHYDRATE (UNII: N57JI2K7WP)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
GLYCERIN (UNII: PDC6A3C0OX)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM BENZOATE (UNII: OJ245FE5EU)
EDETATE SODIUM (UNII: MP1J8420LU)
DIMETHYL MYRISTAMINE (UNII: 5E4O85D8T2)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
TEA TREE OIL (UNII: VIF565UC2G)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
DIMETHYL LAURAMINE (UNII: 6V2OM30I1Z)
CITRUS SINENSIS FRUIT OIL (UNII: WV48LBL15Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77457-010-01	500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/28/2020	08/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/28/2020	08/31/2023

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

Revised: 5/2021

Document Id: c2b1a622-7e8d-0fb6-e053-2995a90aecc5

34390-5

Set id: ab8b14c0-8b33-8cf4-e053-2995a90ae9c2

Version: 4

Effective Time: 20210519

 

Unibeleza