MUSCLE RUB- menthol, camphor, methyl salicylate cream 
Dynarex Corporation

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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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.

Stop Use

Stop Use And Ask A Doctor If:

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

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

Dynarex Muscle Rub

MUSCLE RUB 
menthol, camphor, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-406
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg  in 1 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)40 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE300 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
TROLAMINE (UNII: 9O3K93S3TK)  
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
Blossom Pharmaceuticals677381470manufacture(67777-406)

Revised: 2/2015
Document Id: 5f3125c7-6a19-4f04-abec-268887d57814
Set id: 318c8d1c-4e97-4090-bdaa-3b1220292858
Version: 2
Effective Time: 20150217
 
Dynarex Corporation