FDA.reportPublic FDA data

Control Menstrual Cramp Relief

Manufacturer
Cosmetic Specialty Labs, Inc.
Effective date
2021-08-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:41:51

Label at a glance#

ProductKRT HEAT Muscle Endurance Cream
Active ingredientMENTHOL
Label structure10 sections

Indications and uses

temporarily relieves minor pain associated with: • arthritis • simple backache • muscle strains • sprains • bruises • cramps

Dosage and administration

Adults and children over 12 years: • apply to affected area • massage into painful area until throughly absorbed into skin • repeat as necessary, but no more than 4 time daily Children 12 years or younger: ask a doctor Corrected Section Type

Label contents#

Full prescribing information#

Active Incredient

OTC - ACTIVE INGREDIENT SECTION

Menthol, 3.0%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor pain associated with: • arthritis • simple backache • muscle strains • sprains • bruises • cramps

Warnings

WARNINGS SECTION

for external use only

OTC - WHEN USING SECTION

When using this prodcut• use only as directed • avoid contact with eyes or mucous membranes • do not apply to wounds or damaged skin

OTC - STOP USE SECTION

Stop use and ask a doctor if• condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • irritation develeps

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If pregnant or breast-feeding, ask a health professional before use.

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

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years:• apply to affected area • massage into painful area until throughly absorbed into skin • repeat as necessary, but no more than 4 time daily

Children 12 years or younger: ask a doctor

RECENT MAJOR CHANGES SECTION

Corrected Section Type

Inactive ingredients

INACTIVE INGREDIENT SECTION

Butylene Glycol, Caprylyl Glycol, Carbomer, Cetyl Alcohol, Chamomilla recutita (Matricaria) Flower Extract, Citrus sinensis (Sweet Orange) Peel Oil, Cocos nucifera (Coconut) Oil, Creatine Monohydrate, Dimethicone, Eucalyptus globulus Leaf Oil, Fragrance, Glyceryl Stearate, Laureth-4, Phenoxyethanol, Purified Water, Salvia officinalis (Sage) Extract, Stearic Acid, Triethanolamine.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1442261menthol 3 % Topical CreamPSN3
1442261menthol 30 MG/ML Topical CreamSCD3
1442261menthol 3 % Topical CreamSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58133-750-032024-01-30C16284748780-11030e365-5dc3-111a-e063-dadaa90a10e2bcbe4032-10b2-6556-e053-2995a90a803b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-750-03KRT HEAT Muscle Endurance Cream89 mL in 1 TUBECREAM893

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-750KRT HEAT MUSCLE ENDURANCE CREAM (MENTHOL) CREAM [COSMETIC SPECIALTY LABS, INC.]3Legacy NDC, 1 package rows20210813_bcbe4032-10b2-6556-e053-2995a90a803b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58133-750-03ML - Milliliter58133-750fdfc598e-9822-431b-97b5-739129ecd7e712022-03-09

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58133-75058133-750-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETYL ALCOHOL936JST6JCNIACT
MATRICARIA CHAMOMILLAG0R4UBI2ZZIACT
CITRUS SINENSIS FRUIT OILWV48LBL15QIACT
COCONUT OILQ9L0O73W7LIACT
LAURETH-46HQ855798JIACT
SALVIA OFFICINALIS FLOWERING TOP48JCS720FNIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
CREATINE MONOHYDRATE9603LN7R2QIACT
DIMETHICONE 200RGS4T2AS00IACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
CARBOMER 9404Q93RCW27EIACT

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
c95f0b99-d1bc-2f4c-e053-2995a90a81a2bcbe4032-10b2-6556-e053-2995a90a803b2021-08-12WarningsExact identifier
spl id: c95f0b99-d1bc-2f4c-e053-2995a90a81a2
spl set id: bcbe4032-10b2-6556-e053-2995a90a803b

Reported adverse events (FAERS/openFDA)#

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