MUSCLE RUB- menthol, camphor, methyl salicylate cream

Muscle rub by

Drug Labeling and Warnings

Muscle rub by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation, Blossom Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

MUSCLE RUB 
menthol, camphor, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-406
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	100 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 SALICYLATE	300 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-406-01	85 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/01/2014

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124539)

Establishment
Name	Address	ID/FEI	Business Operations
Blossom Pharmaceuticals		677381470	manufacture(67777-406)