FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Betone, S.A de C.V.
Effective date
2020-06-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:18:47

Label at a glance#

ProductHand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE, POLYAMINOPROPYL BIGUANIDE
Label structure12 sections

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Belzalkonium chloride 0.12 % w/w. Purpose: Antiseptic

Polyaminopropyl Biguanide 0.5% w/w Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, glycerin, disodium cocoamphodiacetate, polysorbate 20, decyl glucoside, iodopropynyl butyñcarmate, methylisothiazolinone, PEF- 12 dimethicone, fragrance, aleo vera and citric acid.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP 150 g NDC: 77824-002-02 PDP 150 gPDP 150 gPI 150 g NDC: 77824-002-02 PI 150 gPI 150 g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2375049benzalkonium chloride 0.12 % / polyaminopropyl biguanide 0.5 % Medicated PadPSN2
2375049benzalkonium chloride 1.2 MG/ML / polyaminopropyl biguanide 5 MG/ML Medicated PadSCD2
2375049benzalkonium chloride 0.12 % / polyaminopropyl biguanide 0.5 % Medicated PadSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77824-003-012022-01-28C16284748780-1d6a99b39-5bef-a426-e053-dadaa90af4c2BETONE- Toallitas Jajón

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77824-003-01Hand Sanitizer150 mL in 1 POUCHCLOTH1502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77824-003HAND SANITIZER (ALCOHOL) CLOTH [BETONE, S.A DE C.V.]2Legacy NDC, 1 package rows20200624_a84eeee0-4475-1241-e053-2995a90afaba.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77824-00377824-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
DIMETHICONE PEG-7 PANTHENYL PHOSPHATE (12 PANTHENOL)7MA9F33W92IACT
ABRONIA FRAGRANS FLOWERXAV1S68QBAIACT
POLYAMINOPROPYL BIGUANIDEDT9D8Z79ETACTIB
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
ALOE VERA FLOWER575DY8C1ERIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
GLYCERINPDC6A3C0OXIACT
DISODIUM COCOAMPHODIACETATE18L9G3U51MIACT
WATER059QF0KO0RIACT
POLYSORBATE 207T1F30V5YHIACT

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
a8c788bd-c265-44e0-e053-2995a90a9975a84eeee0-4475-1241-e053-2995a90afaba2020-06-23WarningsExact identifier
spl id: a8c788bd-c265-44e0-e053-2995a90a9975
spl set id: a84eeee0-4475-1241-e053-2995a90afaba

Reported adverse events (FAERS/openFDA)#

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