Biotipo Sanitizing Hand Wipes

Biotipo Sanitizing Hand Wipes by

Drug Labeling and Warnings

Biotipo Sanitizing Hand Wipes 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 SANITIZING HAND WIPES- belzakonium chloride cloth 
BIOTIPO SANITIZING HAND WIPES- ethyl alcohol cloth 
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 Sanitizing Hand Wipes

Active Ingredient(s)

Alcohol

Alcohol 75% v/v

Benzalkonium

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

For handwashing to decrease bacteria on the skin.

Warnings

For external use only.

Do not use

In the eyes.

If you are allergic to any of the ingredients.

When using this product

if eye contact occurs, rinse thoroughly with water.

Stop use and ask a doctor

if irritation or redness develops and persist for more than 72 hours.

Keep out of reach of children.

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

Directions

Storage. Store at room temperature.
Dispensing. Peel back from Label. Remove wipe(s). Reseal by
pressing label over the opening.
Use. Apply to wipe thoroughly to hands as desired. Allow drying
without wiping.
Disposal. Dispose of used wipes in a trash receptacle after use.
Do not flush.

Inactive ingredients

Water, Glycerin, Phenoxyethanol, Aloe Barbadensis Leaf Extract, Polysorbate 20, Polyaminopropryl Biguanide, 2-bromo-2-nitropropane-1,3-diol, Tocopheryl Acetate, Citric Acid.

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 Sanitizing Hand Wipes (77457-013-01)

Biotipo Sanitizing Hand Wipes (77457-013-02)

Biotipo Sanitizing Hand Wipes (77457-013-03)

Biotipo Sanitizing Hand Wipes (77457-012-01)

Biotipo Sanitizing Hand Wipes (77457-012-02)

BIOTIPO SANITIZING HAND WIPES 
belzakonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77457-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0013 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
2-BROMO-2-METHYLPROPANE (UNII: 5LWO08435U)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77457-012-01	80 in 1 CANISTER	08/04/2020	12/31/2020
1		1.75 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC: 77457-012-02	160 in 1 CANISTER	08/04/2020	12/31/2020
2		1.75 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/04/2020	12/31/2020

BIOTIPO SANITIZING HAND WIPES 
ethyl alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77457-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
2-BROMO-2-METHYLPROPANE (UNII: 5LWO08435U)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77457-013-01	70 in 1 CANISTER	08/10/2020	12/31/2020
1		1.75 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC: 77457-013-02	100 in 1 CANISTER	08/10/2020	12/31/2020
2		1.75 mL in 1 APPLICATOR; Type 0: Not a Combination Product
3	NDC: 77457-013-03	160 in 1 CANISTER	08/10/2020	12/31/2020
3		1.75 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/10/2020	12/31/2020

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

Revised: 5/2021

Document Id: c2b1da77-5ac1-d00f-e053-2995a90ad3da

34390-5

Set id: ac166336-5186-f10e-e053-2995a90a9487

Version: 4

Effective Time: 20210519

 

Unibeleza