ULTRA STRENGHT MUSCLE RUB- methyl salicylate, menthol cream 
Inspec Solutions LLC.

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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Ultra Strength Muscle Rub

Active ingredient

Menthol - 8.00%

Methyl Salicylate - 30.00%

Purpose

Menthol - 8.00% .................................................. External Analgesic

Methyl Salicylate - 30.00% ................................. External Analgesic

Uses Temporary relief for minor aches and pains of muscles and joints.

Warnings

For external use only, Do not bandage tightly, apply to wounds or damaged skin or use with a heating pad.


Caution: Discontinue use if excessive irritation of skin develops, Avoid getting into eyes or mucous membranes, If condition worsens, or symptoms persist for more than 7 days or clear up and occur again within few days, or redness is present, or in conditions affecting children under 12 years of age, discontinue use and consult a physician immediately.

Keep out of reach of children to avoid accidental poisoning, if swallowed, get medical help or contact a poison control center right away.

Directions

Use only as directed. Adults and children 12 years of age and older. Apply to affected area not more than 3 to 4 times daily. Children under 12 years of age: Ask a doctor.

DEA-Cetyl Phosphate

Glyceryl Stearate

Lanolin

Potassium Stearate

Stearic Acid

Water

Muscle Rub

ULTRA STRENGHT MUSCLE RUB 
methyl salicylate, menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72667-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM8 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE30 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POTASSIUM STEARATE (UNII: 17V812XK50)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CETYL PHOSPHATE (UNII: VT07D6X67O)  
WATER (UNII: 059QF0KO0R)  
LANOLIN (UNII: 7EV65EAW6H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72667-010-01113 mL in 1 TUBE; Type 0: Not a Combination Product05/07/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/07/2019
Labeler - Inspec Solutions LLC. (081030372)
Establishment
NameAddressID/FEIBusiness Operations
Inspec Solutions LLC.081030372manufacture(72667-010)

Revised: 5/2019
Document Id: 884eff89-be6e-510f-e053-2995a90ab5dd
Set id: 884eff89-be6d-510f-e053-2995a90ab5dd
Version: 1
Effective Time: 20190507
 
Inspec Solutions LLC.