Label: JOINT AND MUSCLE PAIN- menthol cream
- NDC Code(s): 59899-008-01
- Packager: Shaklee Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated November 11, 2013
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- ACTIVE INGREDIENT
Provides penetrating temporary relief for minor pain in muscles and joints associated with:
- For external use only. Do not use with a heating pad. Do not apply to wounds or damaged skin. Do not bandage tightly after use.
- Avoid contact with eyes.
- Discontinue use and consult a physician if condition worsens, or if symptoms persist more than 7 days, or clear up and occur again within a few days.
- Keep out of reach of children.
If swallowed, get medical help or contact a poison control center right away.Close
- Adults and children over the age of 2: Apply generously to affected area. Massage well into painful area. Repeat as necessary, but not more than 3 to 4 times daily.
- Children under the age of 2: Do not use; consult a physician.
- Inactive Ingredients
Water, Butylene Glycol, Prunus amygdalus dulcis (Sweet Almond) Oil, PEG-12 Glyceryl Distearate, Cetyl Alcohol, Glyceryl Stearate, Cyclomethicone, PEG-100 Stearate, Dimethicone, Aloe barbadensis Leaf Extract, Ehtylhexylglycerin, Carbomer, Caprylyl Glycol, Hexylene Glycol, Phenoxyethanol, Triethanolamine, Xanthan Gum.Close
- PRINCIPAL DISPLAY PANEL
0.07 OZ. (2 g)
Distributed by Shaklee Corporation, 4747 Willow Road, Pleasanton, CA 94588
Item#60700 SAMPLE NOT FOR RESALE XN164A
- INGREDIENTS AND APPEARANCE
JOINT AND MUSCLE PAIN
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59899-008 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALMOND OIL (UNII: 66YXD4DKO9) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CYCLOMETHICONE (UNII: NMQ347994Z) PEG-100 STEARATE (UNII: YD01N1999R) DIMETHICONE (UNII: 92RU3N3Y1O) ALOE VERA LEAF (UNII: ZY81Z83H0X) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HEXYLENE GLYCOL (UNII: KEH0A3F75J) PHENOXYETHANOL (UNII: HIE492ZZ3T) TROLAMINE (UNII: 9O3K93S3TK) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59899-008-01 2 g in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/11/2013 Labeler - Shaklee Corporation (020284076)