FDA.reportPublic FDA data

Gel Hand Sanitizer Wintergreen

Manufacturer
Sovents and Petroleum Inc | Clean All
Effective date
2020-10-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:31:39

Label at a glance#

ProductGel Hand Sanitizer Wintergreen
Active ingredientALCOHOL
Label structure9 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. Do not use on children less than two months of age

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

Alcohol 65% Active ingredientActive ingredient

Purpose

OTC - PURPOSE SECTION

PurposePurposeAntiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

To reduce bacteria on hands. UsesUsesFor 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 on open wounds, avoid eyes, ears and mouth. In case of contact, rinse with water WarningsWarnings

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs., you may report side effects 1-800-315-4467 Stop and ask doctor ifStop and ask doctor if

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childrenKeep out of reach of childrenKeep 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.
  • Do not use on children less than two months of age DirectionsDirections

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylate polymer, bittering agent, fragrance, Inactive ingredientsInactive ingredientsglycerin, hydrogen peroxide, polyethylene glycol, water

Questions

OTC - QUESTIONS SECTION

QuestionsQuestions

1-800-315-4467, Monday Through Friday 8am-5pm

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Front LabelFront Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902574ethanol 65 % Topical GelPSN1
902574ethanol 0.65 ML/ML Topical GelSCD1
902574ethyl alcohol 65 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75660-124-012022-01-28C16284748780-1d6a99b39-fce4-a426-e053-dadaa90af4c2Wintergreen Scented Clean All Gel Hand Sanitizer
75660-124-042022-01-28C16284748780-1d6a99b39-fce4-a426-e053-dadaa90af4c2Wintergreen Scented Clean All Gel Hand Sanitizer
75660-124-052022-01-28C16284748780-1d6a99b39-fce4-a426-e053-dadaa90af4c2Wintergreen Scented Clean All Gel Hand Sanitizer
75660-124-062022-01-28C16284748780-1d6a99b39-fce4-a426-e053-dadaa90af4c2Wintergreen Scented Clean All Gel Hand Sanitizer
75660-124-082022-01-28C16284748780-1d6a99b39-fce4-a426-e053-dadaa90af4c2Wintergreen Scented Clean All Gel Hand Sanitizer
75660-124-162022-01-28C16284748780-1d6a99b39-fce4-a426-e053-dadaa90af4c2Wintergreen Scented Clean All Gel Hand Sanitizer
75660-124-252022-01-28C16284748780-1d6a99b39-fce4-a426-e053-dadaa90af4c2Wintergreen Scented Clean All Gel Hand Sanitizer
75660-124-442022-01-28C16284748780-1d6a99b39-fce4-a426-e053-dadaa90af4c2Wintergreen Scented Clean All Gel Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75660-124-01Gel Hand Sanitizer Wintergreen3785.41 mL in 1 BOTTLE, PLASTICGEL3785.411
75660-124-04Gel Hand Sanitizer Wintergreen4 in 1 BOXGEL41
75660-124-05Gel Hand Sanitizer Wintergreen18927.05 mL in 1 CONTAINERGEL18927.051
75660-124-06Gel Hand Sanitizer Wintergreen6 in 1 BOXGEL61
75660-124-08Gel Hand Sanitizer Wintergreen236.59 mL in 1 BOTTLE, PLASTICGEL236.591
75660-124-16Gel Hand Sanitizer Wintergreen473.17 mL in 1 BOTTLE, PLASTICGEL473.171
75660-124-25Gel Hand Sanitizer Wintergreen9463.52 mL in 1 CONTAINERGEL9463.521
75660-124-44Gel Hand Sanitizer Wintergreen118.29 mL in 1 BOTTLE, PLASTICGEL118.291

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75660-124GEL HAND SANITIZER WINTERGREEN (ALCOHOL) GEL [SOVENTS AND PETROLEUM INC]1Legacy NDC, 8 package rows20201015_b1943dab-e4a0-a819-e053-2995a90a4f9e.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
75660-12475660-124-01, 75660-124-04, 75660-124-05, 75660-124-06, 75660-124-44, 75660-124-08, 75660-124-16, 75660-124-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%)2N8MDB79NAIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
GAULTHERIA PROCUMBENS LEAF2125M16OWNIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT

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
b1944033-45ee-6339-e053-2995a90a09e0b1943dab-e4a0-a819-e053-2995a90a4f9e2020-10-13WarningsExact identifier
spl id: b1944033-45ee-6339-e053-2995a90a09e0
spl set id: b1943dab-e4a0-a819-e053-2995a90a4f9e

Reported adverse events (FAERS/openFDA)#

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