DYNAREX MUSCLE RUB CREAM- menthol and methyl salicylate cream

Dynarex Muscle Rub Cream by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Active Ingredient                                  Purpose

Menthol 10%                                        Topical analgesic

Methyl salicylate  15%  w/w                         Topical analgesic

Purpose

Temporary relief of minor aches and pains of muscle joints associated with:

• simple backache
• arthritis
• strains
• bruises
• sprains

Do not use other than directed.

Indications and Usage

Uses

Temporary relief of minor aches and pains of sore muscles and joints.

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

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

Allantoin, carbomer, cetyl alcohol, dimethicone, disodium EDTA, glycerin, glyceral monostearate, isopropyl myristate, methyparaben, phenoxyethanol, potassium cetyl phoshate, propylparaben, purified water, sodium hydroxide, stearic acid, titanium dioxide, polysorbate 20, Vitamin E, xanthan gum.

Principal Display panel

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INGREDIENTS AND APPEARANCE

DYNAREX MUSCLE RUB CREAM 
menthol and methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-416
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	15 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)
ALLANTOIN (UNII: 344S277G0Z)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-416-01	85 g in 1 TUBE; Type 0: Not a Combination Product	05/16/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/16/2016

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124539)