DYNAREX MUSCLE RUB CREAM- menthol and 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 Cream

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:

´╗┐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.

Stop Use

Stop Use And Ask A Doctor If:

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

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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Dynarex Cream

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)

Revised: 6/2017
Document Id: e54b6cd6-dd30-4eb6-8324-303507b128a9
Set id: 7ca99d69-a463-4ac6-a35d-1b52f50912d4
Version: 2
Effective Time: 20170615
 
Dynarex Corporation