MyoRx 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

image of label

MYORX LOW DOSE PAIN RELIEVING
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59088-954
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BORAGE OIL (UNII: F8XAG1755S)
CAPSAICIN (UNII: S07O44R1ZM)
CARBOMER 934 (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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59088-954-05	59 mL in 1 JAR; Type 0: Not a Combination Product	07/01/2011	10/17/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	07/01/2011	10/17/2024

Labeler - PureTek Corporation (785961046)

Revised: 10/2024

Document Id: 249cddda-1e80-74e1-e063-6394a90a2fe4

Set id: 1c8f98c8-f1bf-4489-bfd4-8ae3a35c2127

Version: 3

Effective Time: 20241016

PureTek Corporation