FLEX FX PAIN RELIEF- menthol cream

FLEX FX Pain Relief by

Drug Labeling and Warnings

FLEX FX Pain Relief by is a Otc medication manufactured, distributed, or labeled by North American Nutraceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredient:

Menthol 1.25%

Topical Analgesic

Indications:

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

Warnings:

• For external use only.
• Avoid contact with eyes.
• If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children.

If swallowed, consult physician.

Do not 

• apply to wounds or damaged skin.
• Do not bandage tightly.

If pregnant or breast feeding,

• contact physician prior  to use.

Directions

• Adults and children two-years of age or older: 
• Apply to affected area not more than three to four times daily.
• Children under two-years of age: consult a physician.

Additional Information:

Store at room temperature.

Other Ingredients:

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Caprylyl Glycol, Celadrin® (proprietary blend of esterified fatty acid carbons), Ethylhexylglycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Hexylene Glycol, C13-14 Isoparaffin, Laureth-7, Oryza Sativa (Rice) Bran Extract, Olea Europaea (Olive) Oil, dl-Panthenol, Phenoxyethanol, Polyacrylamide, Rosmarinus Officinalis (Rosemary) Extract, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E), Triethanolamine,

FLEX FX Pain Relief Cream, 118mL (65121-349-00)

FLEX FX Pain Relief Cream, 59mL (65121-349-01)

INGREDIENTS AND APPEARANCE

FLEX FX PAIN RELIEF 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72390-349
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	12.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETYL TALLOWATE (UNII: MVY7P518D2)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
RICE BRAN (UNII: R60QEP13IC)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ROSEMARY (UNII: IJ67X351P9)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72390-349-00	118 mL in 1 TUBE; Type 0: Not a Combination Product	06/10/2018
2	NDC: 72390-349-01	59 mL in 1 TUBE; Type 0: Not a Combination Product	06/10/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/10/2018

Labeler - North American Nutraceuticals, LLC (081216883)