MUSCLE RUB- menthol, camphor, methyl salicylate cream 
Blossom Pharmaceuticals

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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Blossom Pharmaceuticals 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 acrylates, benzyl alcohol, carbomer, polysorbate 80, trolamine, water.

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Blossom Pharmaceuticals Muscle Rub

blossom mrub.jpg

Blossom Pharma Muscle Rub

MUSCLE RUB 
menthol, camphor, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61767-406
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:61767-406-0185 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/01/2014
Labeler - Blossom Pharmaceuticals (677381470)
Establishment
NameAddressID/FEIBusiness Operations
Blossom Pharmaceuticals677381470manufacture(61767-406)

Revised: 7/2014
Document Id: 7e55067e-7226-4055-b7fd-0399ede09bda
Set id: e5558f12-dc07-46c5-950d-eb3217a62679
Version: 1
Effective Time: 20140701
 
Blossom Pharmaceuticals