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Muscle rub by Dynarex Corporation

Dosage form: cream
Ingredients: MENTHOL 100mg in 1g, CAMPHOR (NATURAL) 40mg in 1g, METHYL SALICYLATE 300mg in 1g
Labeler: Dynarex Corporation
NDC Code: 67777-406

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.

Dynarex Muscle Rub

Active Ingredient

Active Ingredient                                  Purpose

Natural Menthol USP 10%                     Topical analgesic

Methyl salicylate  30%                           Topical analgesic

Camphor 4%                                         Topical analgesic                                 

Purpose

Temporary relief of minor aches and pains.

Indications and Usage

Uses

Temporary relief of minor aches and pains of sore muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Warnings

For external use only.

  • Avoid contact with the eyes or mucous membranes.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.
  • Do not use with heating pad or device.

Stop Use

Stop Use And Ask A Doctor If:

  • Condition worsens, or if symptoms persist for more than 7 days,
  • symptoms clear up and occur again in a few days
  • redness is present or excessive skin irritation develops

If pregnant or breast feeding:

Ask a health professional before use.

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Dosage & Administration

Directions

  • Use only as directed
  • Adults and children 12 years of age and older: apply to the affected areas not more than 3 or 4 times daily.
  • Children under 12 years of age: Consult a physician.

Other Information

Store at 20° - 25°C (68°-77°F)

Inactive Ingredients

Acrylates/C-10-30 Alkyl acrylate, benzyl alcohol, carbomer, polysorbate 80, trolamine, water.

Principle Display Panel

Dynarex Muscle Rub

dynarex mrub.jpg

MUSCLE RUB 
menthol, camphor, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-406
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL100 mg  in 1 g
CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL)40 mg  in 1 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE300 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C 
TROLAMINE 
(C10-C30)ALKYL METHACRYLATE ESTER 
POLYSORBATE 80 
BENZYL ALCOHOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:67777-406-0185 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/01/2014
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
NameAddressID/FEIOperations
Blossom Pharmaceuticals677381470manufacture(67777-406)

 
Dynarex Corporation

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Medically reviewed on Feb 19, 2018

Further information

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

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