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Muscle Rub by Galentic Pharma (India) Private Limited

Medically reviewed on December 20, 2017

Dosage form: cream
Ingredients: MENTHOL, UNSPECIFIED FORM 100mg in 1g, Methyl Salicylate 150mg in 1g
Labeler: Galentic Pharma (India) Private Limited
NDC Code: 50382-015

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.

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)

MUSCLE RUB 
menthol, unspecified form and methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-015
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM100 mg  in 1 g
Methyl Salicylate (Salicylic Acid) Methyl Salicylate150 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
Glyceryl Monostearate 
Methylparaben 
PROPYLPARABEN 
Propylene Glycol 
Polysorbate 80 
Water 
Stearic Acid 
Trolamine 
Lanolin 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:50382-015-151 TUBE in 1 CARTON
185 g in 1 TUBE
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/FEIOperations
Galentic Pharma (India) Private Limited864201135ANALYSIS(50382-015), MANUFACTURE(50382-015), PACK(50382-015), REPACK(50382-015), STERILIZE(50382-015)
Establishment
NameAddressID/FEIOperations
Galentic Pharma (India) Private Limited650970176ANALYSIS(50382-015), MANUFACTURE(50382-015), PACK(50382-015), REPACK(50382-015), STERILIZE(50382-015)

 
Galentic Pharma (India) Private Limited

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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