MyoRx Low Dose Pain Relieving

Dosage form: cream
Ingredients: MENTHOL 5uL in 1mL
Labeler: PureTek Corporation
NDC Code: 59088-954

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.

Drug Facts

Active ingredient

Menthol  0.5%

Purpose

Topical Analgesic

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

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

Warnings

For external use only.

Do not
  • apply on wounds or damaged skin
  • bandage tightly

When using this product

avoid contact with the eyes

Stop use and ask a doctor if
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Directions

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: consult a doctor.

Inactive ingredients

Aloe Barbadensis (Aloe Vera) Leaf Juice, Borago Officinalis Seed Oil, Capsaicin, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Eucalyptus Globulus Leaf Oil, Fructose, Menhaden Oil, Methyl Salicylate, Methylparaben, Phenoxyethanol, Propylene Glycol, Propylparaben, Purified Water, Squalane, Stearic Acid, Stearyl Alcohol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Triethanolamine, Vitis Vinifera (Grape) Seed Oil.

Store at controlled room temperature 59°-86°F (15°-30°C).

Label

MYORX  LOW DOSE PAIN RELIEVING
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-954
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL5 uL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
BORAGE OIL 
CAPSAICIN 
CARBOMER 934 
POLYOXYL 20 CETOSTEARYL ETHER 
CETOSTEARYL ALCOHOL 
CETYL ALCOHOL 
CITRIC ACID MONOHYDRATE 
EUCALYPTUS OIL 
FRUCTOSE 
HYDROGENATED MENHADEN OIL 
METHYL SALICYLATE 
METHYLPARABEN 
PHENOXYETHANOL 
PROPANEDIOL 
PROPYLPARABEN 
WATER 
SQUALANE 
STEARIC ACID 
STEARYL ALCOHOL 
EDETATE SODIUM 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
TROLAMINE 
GRAPE SEED OIL 
Packaging
#Item CodePackage Description
1NDC:59088-954-0559 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/01/2011
Labeler - PureTek Corporation (785961046)
Establishment
NameAddressID/FEIOperations
PureTek Corporation785961046manufacture, label, pack, outsourcing human drug compounding, relabel, repack

Revised: 07/2011
 
PureTek Corporation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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