MUSCLE RUB CREAM- menthol 10%, methyl salicylate 15% cream

Muscle Rub Cream by

Drug Labeling and Warnings

Muscle Rub Cream by is a Otc medication manufactured, distributed, or labeled by Trifecta Pharmaceuticals USA, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Menthol 10%

Active Ingredient

Methyl Salicylate 15%

PURPOSE

Topical Analgesic

INDICATIONS & USAGE

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains

Warnings

For external use only

Do not use:

• On wounds or damaged, broken, (open) or irritated skin
• With a heating pad

Ask a doctor before use if you are pregnant or breast feeding.

When using this product

• Avoid contact with eyes or mucous membrane
• Do not bandage tightly

Stop Use and ask a doctor

• Conditions worsens or does not improve within 7 days
• Symptoms clear up and occur again within a few days
• Excessive skin irritation develops

A temporary burning sensation may occur upon application, but generally disappears in a few days

Keep out of the reach of Children

If swallowed, get medical help or contact a Poison Control Center immediately

Directions

• Adults and children 12 years of age or older. Apply to the affected area not more than 3 to 4 times daily.

Children under 12 years of age. consult a doctor

• Unless treating hands, wash hands thoroughly with soap and water immediately after use.

Other Information

• Store at controlled room temperature 20º-25ºC (68º-77ºF)

Questions ? Call 1-888-296-9067

Inactive Ingredients

Carbomer 940, Cetyl alcohol, Glycerol, Glyceryl monostearate, Methylparaben, Polysorbate 80, Propylparaben, Purified Water, Stearic acid, Trolamine

Distributed By

Trifecta Pharmaceuticals USA, LLC.

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301

www.trifecta-pharma.com

Packaging

INGREDIENTS AND APPEARANCE

MUSCLE RUB CREAM 
menthol 10%, methyl salicylate 15% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-024
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.1 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CARBOMER 940 (UNII: 4Q93RCW27E)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-024-05	1 in 1 BOX	12/29/2016
1		15 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/29/2016

Labeler - Trifecta Pharmaceuticals USA, LLC. (079424163)