FDA.reportPublic FDA data

Alcohol Antispetic 62% Topical Solution Hand Sanitizer

Manufacturer
Wink Naturals, LLC | Wasatch Product Development, LLC
Effective date
2020-05-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:14:57

Label at a glance#

ProductAlcohol Antispetic 62% Topical Solution Hand Sanitizer
Active ingredientALCOHOL
Label structure10 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#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Alcohol 62% v/v. Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

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.

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

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.

Do not use

OTC - DO NOT USE SECTION

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

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, Fragrance, Carbomer, PEG-40 Hydrogenated Castor Oil, Chlorphenesin, Aminomethyl Propanol

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Wink Naturals

Alcohol Antiseptic 62% Topical Solution

Hand Sanitizer

Non-sterile

4 FL OZ (118 mL)

Hand Santiizer v1Hand Santiizer v1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
247835ethanol 62 % Topical SolutionPSN1
247835ethanol 0.62 ML/ML Topical SolutionSCD1
247835ethanol 62 % Topical SolutionSY1
247835ethyl alcohol 62 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77041-002-012022-01-28C16284748780-1d6a99b39-f426-a426-e053-dadaa90af4c2Alcohol Antispetic 62% Topical Solution Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77041-002-01Alcohol Antispetic 62% Topical Solution Hand Sanitizer118 mL in 1 BOTTLESOLUTION1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77041-002ALCOHOL ANTISPETIC 62% TOPICAL SOLUTION HAND SANITIZER (ALCOHOL) SOLUTION [WINK NATURALS, LLC]1Legacy NDC, 1 package rows20200528_a6958ee2-841f-f777-e053-2a95a90ab78e.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77041-00277041-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CHLORPHENESINI670DAL4SZIACT
AMINOMETHYLPROPANOLLU49E6626QIACT

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
a69552fd-7668-dc67-e053-2995a90a83e2a6958ee2-841f-f777-e053-2a95a90ab78e2020-05-26WarningsExact identifier
spl id: a69552fd-7668-dc67-e053-2995a90a83e2
spl set id: a6958ee2-841f-f777-e053-2a95a90ab78e

Reported adverse events (FAERS/openFDA)#

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