Label: NATURES SUNSHINE PRODUCTS EVERFLEX TOPICAL ANALGESIC PAIN RELIEF- menthol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 44717-532-01 - Packager: Wasatch Product Development, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated March 9, 2011
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ACTIVE INGREDIENT
Active Ingredients Purpose
Menthol 1.25% Topical analgesicEverflex pain relief cream provides temporary relief from aching joints and the surrounding tissues. Ever flex contains a proprietary blend of esterified fatty acids which is clinically proven to provide arthritis relief, plus MSM.
-If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of product and consult a physician
-Do not apply to wounds or damaged skin
-Do not bandage tightly
Other Information: Store in a cool, dry place.
Inactive Ingredients: Water, Glyceryl Stearate, Glycerin, Methylsulfonylmethane (MSM), Cetyl Myristoleate, Olea Europaea (Olive) Fruit Oil, Cetyl Myristate, Lecithin, Menthol, Tocopheryl Acetate, Benzyl Alcohol, Phenoxyethanol, Carbomber, PEG-100 Stearate, Potassium Hydroxide, Cetyl Palmitoleate, Cetyl Oleate, Cetyl Palmitate, Cetyl Laurate, Methylparaben, Propylparaben, Ethylparaben, Butylparaben, Isobutylparaben.
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INGREDIENTS AND APPEARANCE
NATURES SUNSHINE PRODUCTS EVERFLEX TOPICAL ANALGESIC PAIN RELIEF
menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44717-532 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1.25 g in 100 g Inactive Ingredients Ingredient Name Strength GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERIN (UNII: PDC6A3C0OX) CETYL MYRISTOLEATE (UNII: 87P8K33Q5X) OLIVE OIL (UNII: 6UYK2W1W1E) CETYL MYRISTATE (UNII: 7OPL833Q4D) MENTHOL (UNII: L7T10EIP3A) BENZYL ALCOHOL (UNII: LKG8494WBH) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-100 STEARATE (UNII: YD01N1999R) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) CETYL PALMITOLEATE (UNII: 962I97113K) CETYL OLEATE (UNII: 78K2L26L8N) CETYL PALMITATE (UNII: 5ZA2S6B08X) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) ETHYLPARABEN (UNII: 14255EXE39) BUTYLPARABEN (UNII: 3QPI1U3FV8) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44717-532-01 57 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/13/2010 Labeler - Wasatch Product Development, LLC (962452533) Registrant - Nature's Sunshine Products, Inc. (081832388) Establishment Name Address ID/FEI Business Operations Wasatch Product Development, LLC 962452533 manufacture