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Muscle Rub by Universal Distribution Center LLC

Medically reviewed on April 16, 2018

Dosage form: gel
Ingredients: MENTHOL 0.025g in 1g
Labeler: Universal Distribution Center LLC
NDC Code: 52000-020

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 Gel

Active Ingredient

Menthol 2.5%

Purpose

Topical Analgesic

Uses

  • Provides soothing relief of minor arthritis pain, aching muscles, joints and backaches.

Warnings

For external use only. Use only as directed. Keep out of reach of children to avoid accidental poisoning.

  • Avoid contact with eyes or mucous membranes.
  • Discontinue use if excessive irritation of the skin develops.
  • Do not bandage tightly, apply to wounds, broken or irritated skin, or use with a heating pad.
  • If condition worsens, or if symptoms persist for more than 10 days or clear-up and occur again within a few days, if skin redness or irritation develops, discontinue use of this product and consult a doctor.
  • For arthritis like conditions in children under 12, do not use. Consult a doctor.

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily and gently massage until gel disappears.
  • Children under 12 years of age: do not use, consult a doctor

Other Information

  • Store at controlled room temperature 15°C to 30°C (59°F to 86°F)
  • Lot No. & Exp. Date: see crimp of tube.

Inactive Ingredients

Camphor, Carbomer, DMDM Hydantoin, Isoceteth, Isopropyl Alcohol, PEG-40 Hydrogenated Castor Oil, Sodium Hydroxide, Water

PRINCIPAL DISPLAY PANEL

MUSCLE RUB GEL

NET WT 1.25 OZ (35 g)

MUSCLE RUB 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-020
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL0.025 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (SYNTHETIC) 
CARBOMER 940 
DMDM HYDANTOIN 
ISOCETETH-20 
ISOPROPYL ALCOHOL 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
SODIUM HYDROXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:52000-020-371 TUBE in 1 BOX
1NDC:52000-020-3835 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/15/2015
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIOperations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52000-020)

 
Universal Distribution Center LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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