MUSCLE RUB PREMIER VALUE- menthol 8.00% methyl salicylate 30.00% cream 
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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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Drug Facts

Active ingredient                 Menthol
Active ingredient                 Methyl Salicylate

External Analgesic

Uses

For temporary relief if minor aches and pains of muscles and joints

Warnings

For external use only

Do not use • on wounds or damaged skin • in large quantities, particularity over raw surfaces • with a healing pad

When using this product avoid contact with eyes • do not bandage tightly or use with a heating pad

Stop use and ask a doctor if rash occurs
• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days
• irritation develops

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

Directions

Directions
Use only as directed
• adults and children 12 years of age and older: spray on affected area, not more than 3 to 4 times daily
• children under 12 years of age: consult a doctor

Inactive ingredients

DEA-Cetyl Phosphate
Glyceryl Stearate
Lanolin
Potassium Stearate
Stearic Acid
Water

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MUSCLE RUB  PREMIER VALUE
menthol 8.00% methyl salicylate 30.00% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-186
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol8 g  in 106 mL
Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) Methyl Salicylate30 g  in 106 mL
Inactive Ingredients
Ingredient NameStrength
DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
Lanolin (UNII: 7EV65EAW6H)  
Potassium Stearate (UNII: 17V812XK50)  
Stearic Acid (UNII: 4ELV7Z65AP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-186-001 in 1 CARTON10/04/2011
1120 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/04/2011
Labeler - Premier Value (101668460)
Registrant - Product Quest (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest927768135manufacture(68016-186) , label(68016-186)

Revised: 9/2017
Document Id: b20c28d5-3ec7-4c31-8292-003a1e59db26
Set id: e72ddf0b-830e-4101-b104-c2754d7558b4
Version: 1
Effective Time: 20170926
 
Premier Value