Muscle Rub

Muscle Rub

Drug Labeling and Warnings

Drug Details

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MUSCLE RUB- menthol, unspecified form and methyl salicylate cream 
Galentic Pharma (India) Private Limited

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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Muscle Rub

ACTIVE INGREDIENT

Menthol 10%

Methyl Salicylate 15%

PURPOSE

Topical analgesic

USES

Temporarily relieves the minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains.

WARNINGS

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 membrane
  • 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

Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.

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

OTHER INFORMATION

  • Store at 15° to 25 °C (59° to 77°F)
  • Lot No. & Exp. Date : See box or see crimp of tube

INACTIVE INGREDIENTS

Citric Acid, Glyceryl Monostearate, Lanolin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Polysorbate 80, Stearic Acid, Trolamine

Manufactured by : Galentic Pharma (India) Pvt. Ltd., Plot No. 5-B & 5-C, Sector III, Kandla Special Economic Zone,
Gandhidham-370 230, Gujrat. India

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

Galentic

Muscle Rub
ULTRA STRENGTH

Pain Relieving Cream
Non-Greasy

NET WT.
3 OZ. (85g)

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
MUSCLE RUB 
menthol, unspecified form and methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50382-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM100 mg  in 1 g
Methyl Salicylate (UNII: LAV5U5022Y) (Salicylic Acid - UNII:O414PZ4LPZ) Methyl Salicylate150 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Methylparaben (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Water (UNII: 059QF0KO0R)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Trolamine (UNII: 9O3K93S3TK)  
Lanolin (UNII: 7EV65EAW6H)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50382-015-151 in 1 CARTON06/01/2012
185 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34806/01/2012
Labeler - Galentic Pharma (India) Private Limited (915110464)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma (India) Private Limited864201135ANALYSIS(50382-015) , MANUFACTURE(50382-015) , PACK(50382-015) , REPACK(50382-015) , STERILIZE(50382-015)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma (India) Private Limited650970176ANALYSIS(50382-015) , MANUFACTURE(50382-015) , PACK(50382-015) , REPACK(50382-015) , STERILIZE(50382-015)

Revised: 12/2017
 
Galentic Pharma (India) Private Limited


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