KRT ATHLETIC MUSCLE GEL- trolamine salicylate gel 
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

Triethanolamine Salicylate 10%

Purpose

Topical analgesic

Uses

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

Warnings

for external use only

Allergy alert:

If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

When using this product • 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 develops

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

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

Directions:

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

Children 12 years or younger: ask a doctor

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Arnica montana Flower Extract, Butylene Glycol, Caprylyl Clycol, Carbomer, Chamomila recutita (Matricaria) Flower Extract, Citric Acid, Citrus sinensis (Sweet Orange) Peel Oil, Creatine Monohydrate, Fragrance, Lactic Acid, Lauric Acid, Phenoxyethanol, Purified Water, Salvia officinalis (Sage) Extract, Sodium Caprylate, Sorbitol, Triethanolamine.

Package Label

Principal Display Panel

KRT ATHLETIC MUSCLE GEL 
trolamine salicylate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-751
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) TROLAMINE SALICYLATE10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 940 (UNII: 4Q93RCW27E)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
TROLAMINE (UNII: 9O3K93S3TK)  
ORANGE OIL, DISTILLED (UNII: H4QNH2ZN7A)  
SAGE (UNII: 065C5D077J)  
SODIUM CAPRYLATE (UNII: 9XTM81VK2B)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CREATINE MONOHYDRATE (UNII: 9603LN7R2Q)  
LACTIC ACID (UNII: 33X04XA5AT)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHAMOMILE (UNII: FGL3685T2X)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
LAURIC ACID (UNII: 1160N9NU9U)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Colorwhite (opaque) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58133-751-0389 mL in 1 TUBE; Type 0: Not a Combination Product03/10/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/10/2021
Labeler - Cosmetic Specialty Labs, Inc. (032973000)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Specialty Labs, Inc.032973000manufacture(58133-751) , label(58133-751) , analysis(58133-751) , pack(58133-751)

Revised: 8/2021
Document Id: c95f2a3d-2423-e87b-e053-2995a90af723
Set id: bd3644fc-f33e-7e95-e053-2a95a90a160c
Version: 2
Effective Time: 20210812
 
Cosmetic Specialty Labs, Inc.