FDA.reportPublic FDA data

Topicare Therapeutics Hand Sanitizer

Manufacturer
Topicare Management, LLC
Effective date
2020-09-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:44

Label at a glance#

ProductTopicare Therapeutics Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 73.3%

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

On 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.

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.

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

Wet hands thoroughly with product and allow to dry without wiping.

Other information

STORAGE AND HANDLING SECTION

Store between 15-30°C (59-86°F)

Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Klucel H hydroxypropyl cellulose, Deionized Water, Ceraphyl 31 ester, Glycerin

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

59mL NDC: 70112-300-02

59mL label59mL label

118mL NDC 70112-300-04

118mL label118mL label

236mL NDC 70112-300-08

236mL label236mL label

473mL NDC 70112-300-16

473mL label473mL label

3.79L NDC 70112-300-01

3.79L label3.79L label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2288239ethanol 73.3 % Topical GelPSN1
2288239ethanol 0.733 ML/ML Topical GelSCD1
2288239ethanol 73.3 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70112-300-012022-01-28C16284748780-1d6a99b39-60c4-a426-e053-dadaa90af4c2Topicare Therapeutics Hand Sanitizer
70112-300-022022-01-28C16284748780-1d6a99b39-60c4-a426-e053-dadaa90af4c2Topicare Therapeutics Hand Sanitizer
70112-300-042022-01-28C16284748780-1d6a99b39-60c4-a426-e053-dadaa90af4c2Topicare Therapeutics Hand Sanitizer
70112-300-082022-01-28C16284748780-1d6a99b39-60c4-a426-e053-dadaa90af4c2Topicare Therapeutics Hand Sanitizer
70112-300-162022-01-28C16284748780-1d6a99b39-60c4-a426-e053-dadaa90af4c2Topicare Therapeutics Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70112-300-01Topicare Therapeutics Hand Sanitizer3790 mL in 1 JUGGEL37901
70112-300-02Topicare Therapeutics Hand Sanitizer59 mL in 1 BOTTLEGEL591
70112-300-04Topicare Therapeutics Hand Sanitizer118 mL in 1 BOTTLEGEL1181
70112-300-08Topicare Therapeutics Hand Sanitizer236 mL in 1 BOTTLEGEL2361
70112-300-16Topicare Therapeutics Hand Sanitizer473 mL in 1 BOTTLEGEL4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70112-300TOPICARE THERAPEUTICS HAND SANITIZER (ETHYL ALCOHOL) GEL [TOPICARE MANAGEMENT, LLC]1Legacy NDC, 5 package rows20200919_af73ae4b-bced-2e21-e053-2a95a90a2dce.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70112-30070112-300-01, 70112-300-02, 70112-300-04, 70112-300-08, 70112-300-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
MYRISTYL LACTATE1D822OC34XIACT
LAURYL LACTATEG5SU0BFK7OIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
CETYL LACTATEA7EVH2RK4OIACT

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
af73a12e-777b-4f80-e053-2a95a90ae477af73ae4b-bced-2e21-e053-2a95a90a2dce2020-09-16WarningsExact identifier
spl id: af73a12e-777b-4f80-e053-2a95a90ae477
spl set id: af73ae4b-bced-2e21-e053-2a95a90a2dce

Reported adverse events (FAERS/openFDA)#

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