PAIN RELIEF RUB- camphor,menthol, methyl salicylate cream 
Topco Associates 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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Drug Facts

Active Ingredients


Camphor 4%

Menthol 10%

Methyl Salicylate 30%


Uses

temporarily relieves the minor aches and pains of muscle and joints associated with: simple backache, arthritis, bruises, sprains

For external use only.

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

Ask a doctor before use if you have

redness over the affected area

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Keep out of reach of children to avoid accidental ingestion.

If swallowed, get medical help or contact a Poison Control Center immediately

Directions

             apply to affected area not more than 3 to 4 times daily

Other information

Inactive Ingredients

carbomer940, cetyl alcohol, glyceryl monostearate, isopropyl myristate, polysorbate60, purified water, stearic acid, trolamine

Pain Relief Rubimage of carton label

Topical analgesic

Topical analgesic

Topical analgesic

PAIN RELIEF RUB 
camphor,menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-042
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD) (SALICYLIC ACID - UNII:O414PZ4LPZ) MENTHYL SALICYLATE, (+/-)-30 g  in 100 g
Camphor (Natural) (UNII: N20HL7Q941) (Camphor (Natural) - UNII:N20HL7Q941) Camphor (Natural)4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER 940 (UNII: 4Q93RCW27E)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-042-041 in 1 BOX
1114 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/01/2013
Labeler - Topco Associates LLC (006935977)

Revised: 7/2013
Document Id: 9ef393b1-8484-4321-9ad7-c9be0a7bf15e
Set id: 9e4c7e73-910c-4a75-8570-2d650006ce93
Version: 1
Effective Time: 20130726
 
Topco Associates LLC