KRT HEAT MUSCLE ENDURANCE CREAM- menthol cream 
Cosmetic Specialty Labs, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Incredient

Menthol, 3.0%

Purpose

Topical analgesic

Uses

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

Warnings

for external use only

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

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

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:

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

Inactive ingredients

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

Principal Display Panel

KRT HEAT MUSCLE ENDURANCE CREAM 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-750
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)  
CITRUS SINENSIS FRUIT OIL (UNII: WV48LBL15Q)  
COCONUT OIL (UNII: Q9L0O73W7L)  
LAURETH-4 (UNII: 6HQ855798J)  
SALVIA OFFICINALIS FLOWERING TOP (UNII: 48JCS720FN)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
CREATINE MONOHYDRATE (UNII: 9603LN7R2Q)  
DIMETHICONE 200 (UNII: RGS4T2AS00)  
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
WATER (UNII: 059QF0KO0R)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58133-750-0389 mL in 1 TUBE; Type 0: Not a Combination Product03/04/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/04/2021
Labeler - Cosmetic Specialty Labs, Inc. (032973000)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Specialty Labs, Inc.032973000manufacture(58133-750) , pack(58133-750) , label(58133-750) , analysis(58133-750)

Revised: 8/2021
Document Id: c95f0b99-d1bc-2f4c-e053-2995a90a81a2
Set id: bcbe4032-10b2-6556-e053-2995a90a803b
Version: 3
Effective Time: 20210812
 
Cosmetic Specialty Labs, Inc.