MUSCLE RUB ULTRA - camphor,menthol, methyl salicylate cream 
NeoPharm Co., Ltd.

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:

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

carbomer, edetate disodium, glyceryl stearate se, lanolin, polysorbate 80, potassium hydroxide, purified water, stearic acid, trolamine

Questions?

call 1-800-883-0085, weekdays, 9AM -5PM PST

Muscle Rub Ultraimage of carton label

Topical analgesic

Topical analgesic

Topical analgesic

MUSCLE RUB ULTRA 
camphor,menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-0659
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) (Menthyl Salicylate - UNII:43XOA705ZD) Menthyl Salicylate30 g  in 100 g
Camphor (Natural) (UNII: N20HL7Q941) (Camphor (Natural) - UNII:N20HL7Q941) Camphor (Natural)4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LANOLIN (UNII: 7EV65EAW6H)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51141-0659-41 in 1 BOX
1113 g in 1 TUBE
2NDC:51141-0659-11 in 1 BOX
265 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/16/2010
Labeler - NeoPharm Co., Ltd. (631101883)
Registrant - NeoPharm Co., Ltd. (631101883)
Establishment
NameAddressID/FEIBusiness Operations
NeoPharm Co., Ltd.631101883manufacture

Revised: 8/2010
Document Id: 6ee5cd72-9e86-4526-af8a-417536369c62
Set id: f3d7d48b-adc4-4b3b-bbf3-0261a1a22d08
Version: 2
Effective Time: 20100824
 
NeoPharm Co., Ltd.