FDA.reportPublic FDA data

DR WOLFES COOL THERAPY

Manufacturer
SOMBRA COSMETICS INC.
Effective date
2023-03-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:54:25

Label at a glance#

ProductDR WOLFES COOL THERAPY
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joints associated with: simple backaches, strains, bruises, and sprains

Dosage and administration

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age: consult a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 6%

Purpose

OTC - PURPOSE SECTION

Purpose
External Analgesic

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains of muscles and joints associated with: simple backaches, strains, bruises, and sprains

Warnings

WARNINGS SECTION

For external use only. Do not use on wounds or damaged skin or with a heat source. If pregnant or breastfeeding, consult a healthcare
professional before use. When using this product : avoid bandaging tightly, avoid contact with eyes, Keep out of reach of children.

Stop use and ask doctor if: condition worsens, symptoms persist for more than 7 days, symptoms clear up and occur again within a few days.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age: consult a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, carbomer, decyl glucoside, purified water, citrus grandis (grapefruit) seed extract, camellia sinensis (green tea) leaf extract, citrus limon (lemon) peel oil, spiraea ulmaria flower (queen of the prairie) extract, rosa damascena flower water, sodium carbonate, glycerin, hamamelis virginiana (witch hazel) leaf extract, yucca schidigera root extract, phenoxyethanol, caprylyl glycol

Questions or Comments

OTC - QUESTIONS SECTION

1-800-225-3963

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415976menthol 6 % Topical GelPSN3
415976menthol 0.06 MG/MG Topical GelSCD3
415976menthol 6 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-1020-42025-01-30C16284748780-1f386c649-9cf1-0266-e053-dadaa90a7c1aDr Wolfes Cool Therapy
61577-1020-42023-03-09C16284748780-1f386c649-9cf1-0266-e053-dadaa90a7c1aDr Wolfes Cool Therapy
61577-1020-42023-01-30C16284748780-1f386c649-9cf1-0266-e053-dadaa90a7c1aDr Wolfes Cool Therapy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-1020-4DR WOLFES COOL THERAPY113.4 g in 1 JARGEL113.43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-1020DR WOLFES COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]3Legacy NDC, 1 package rows20230310_119314c2-f9ad-4b39-abd4-8f8cc6fadeaf.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61577-102061577-1020-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
WATER059QF0KO0RIACT
GRAPEFRUIT SEED OIL598D944HOLIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
FILIPENDULA ULMARIA FLOWER06L18L32G6IACT
ROSA CENTIFOLIA FLOWER OILH32V31VMWYIACT
SODIUM CARBONATE45P3261C7TIACT
GLYCERINPDC6A3C0OXIACT
WITCH HAZEL101I4J0U34IACT
YUCCA SCHIDIGERA ROOTE2H9ET15ATIACT
LEMON OILI9GRO824LLIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
MENTHOLL7T10EIP3AACTIB

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
5a2b5025-4f43-4a9b-9603-cd18682da95c119314c2-f9ad-4b39-abd4-8f8cc6fadeaf2023-03-09WarningsExact identifier
spl id: 5a2b5025-4f43-4a9b-9603-cd18682da95c
spl set id: 119314c2-f9ad-4b39-abd4-8f8cc6fadeaf

Reported adverse events (FAERS/openFDA)#

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