Muscle and Joint

Muscle and Joint

Drug Labeling and Warnings

Drug Details

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MUSCLE AND JOINT- menthol, unspecified form gel 
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 and Joint

Drug Facts

ACTIVE INGREDIENT

Menthol 2.5%

PURPOSE

Topical Analegesic

USES

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, sprains, and bruises

WARNINGS

For External Use Only.

Do not use

  • On wounds or damaged skin
  • With a heating pad
  • On children 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

Keep out of Reach of Children. If swallowed, get medical help of contact a Poison Control Center immediately.

DIRECTIONS

  • Adults 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 between 15° to 30°C (59° to 86°F)

INACTIVE INGREDIENT

Camphor, Carbomer 980, Isopropyl alcohol, Methylparaben, Polysorbate 60, Potassium Sorbate, Trolamine, Purified water

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 & Joint
VANISHING SCENT GEL

Quick Relief

NET WT.
3 OZ. (85g)

PRINCIPAL DISPLAY PANEL 85 g Tube Carton
MUSCLE AND JOINT 
menthol, unspecified form gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50382-016
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Camphor (Synthetic) (UNII: 5TJD82A1ET)  
Polysorbate 60 (UNII: CAL22UVI4M)  
Methylparaben (UNII: A2I8C7HI9T)  
Trolamine (UNII: 9O3K93S3TK)  
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)  
Isopropyl Alcohol (UNII: ND2M416302)  
Water (UNII: 059QF0KO0R)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50382-016-151 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(50382-016) , MANUFACTURE(50382-016) , PACK(50382-016) , REPACK(50382-016) , STERILIZE(50382-016)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma (India) Private Limited650970176ANALYSIS(50382-016) , MANUFACTURE(50382-016) , PACK(50382-016) , REPACK(50382-016) , STERILIZE(50382-016)

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


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