FDA.reportPublic FDA data

Biotipo Sanitizing Hand Wipes

Manufacturer
Unibeleza Industria e Comercio de Cosmeticos Ltda
Effective date
2020-08-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:18:49

Label at a glance#

ProductBiotipo Sanitizing Hand Wipes
Active ingredientBENZALKONIUM CHLORIDE, ALCOHOL
Label structure11 sections

Indications and uses

For handwashing to decrease bacteria on the skin.

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol

Alcohol 75% v/v

Benzalkonium

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

In the eyes.

If you are allergic to any of the ingredients.

When using this product

OTC - WHEN USING SECTION

if eye contact occurs, rinse thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

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)

Biotipo75Alc070Biotipo75Alc070

Biotipo Sanitizing Hand Wipes (77457-013-02)

Biotipo75Alc100Biotipo75Alc100


Biotipo Sanitizing Hand Wipes (77457-013-03)
Biotipo75Alc160Biotipo75Alc160

Biotipo Sanitizing Hand Wipes (77457-012-01)

BiotipoWB080BiotipoWB080 Biotipo Sanitizing Hand Wipes (77457-012-02)

BiotipoWB160BiotipoWB160

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77457-01277457-012-01, 77457-012-02
77457-01377457-013-01, 77457-013-02, 77457-013-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
POLYAMINOPROPYL BIGUANIDEDT9D8Z79ETIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
2-BROMO-2-METHYLPROPANE5LWO08435UIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
POLYAMINOPROPYL BIGUANIDEDT9D8Z79ETIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
2-BROMO-2-METHYLPROPANE5LWO08435UIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c2b1da77-5ac1-d00f-e053-2995a90ad3daac166336-5186-f10e-e053-2995a90a94872021-05-19WarningsExact identifier
spl set id: ac166336-5186-f10e-e053-2995a90a9487

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.