MYORX PAIN RELIEVING- menthol cream

MyoRx by

Drug Labeling and Warnings

MyoRx by is a Otc medication manufactured, distributed, or labeled by PureTek Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Menthol  2.0%

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.

STORAGE AND HANDLING

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

Label

INGREDIENTS AND APPEARANCE

MYORX  PAIN RELIEVING
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59088-962
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BORAGE SEED OIL (UNII: F8XAG1755S)
CAPSAICIN (UNII: S07O44R1ZM)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FRUCTOSE (UNII: 6YSS42VSEV)
HYDROGENATED MENHADEN OIL (UNII: 736VD7888J)
METHYL SALICYLATE (UNII: LAV5U5022Y)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPANEDIOL (UNII: 5965N8W85T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SQUALANE (UNII: GW89575KF9)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TROLAMINE (UNII: 9O3K93S3TK)
GRAPE SEED OIL (UNII: 930MLC8XGG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59088-962-05	59 mL in 1 JAR; Type 0: Not a Combination Product	01/28/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/28/2010

Labeler - PureTek Corporation (785961046)