Label: MIND BODY MATRIX PAIN RELIEF- menthol cream

  • NDC Code(s): 72268-175-01, 72268-175-04, 72268-175-10
  • Packager: Functional Energetic, Inc.
  • 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 April 20, 2018

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  • DRUG FACTS:

  • ACTIVE INGREDIENT:

    MENTHOL 1.50%

    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:

    ALOE BARBADENSIS (ALOE VERA GEL) JUICE, AQUA (DEIONIZED WATER), ARNICA MONTANA FLOWER EXTRACT, BOSWELLIA SERRATA EXTRACT, CALENDULA 0FFICINALIS EXTRACT, CETEARYL OLIVATE, CETYL ALCOHOL, CHAMOMILLA RECUTITA (CHAMOMILE) EXTRACT, CITRUS LIMONUM MEDICA (LEMON BALM) EXTRACT, G-AMINOBUTYRIC ACID, GLUCONOLACTONE, GLYCERIN, GLYCERYL STEARATE, HELIANTHUS
    ANNUUS (SUNFLOWER) OIL, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, LECITHIN, MELALEUCA ALTERNIFOLIA (TEA TREE) OIL, MENTHA
    PIPERITA (PEPPERMINT) OIL, METHYL SALICYLATE (WINTERGREEN) OIL, METHYLSULFONYLMETHANE (MSM), SILICA, SODIUM BENZOATE, SORBITAN OLIVATE, TAPIOCA STARCH, L-THEANINE, XANTHAN GUM, ZEMEA (CORN) PROPANEDIOL.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    MIND BODY MATRIX PAIN RELIEF 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72268-175
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHAMOMILE (UNII: FGL3685T2X)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    THEANINE (UNII: 8021PR16QO)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CORN (UNII: 0N8672707O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72268-175-011 in 1 BOX04/20/2018
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:72268-175-041 in 1 BOX04/20/2018
    2120 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:72268-175-101 in 1 CARTON04/20/2018
    33840 mL in 1 JUG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/20/2018
    Labeler - Functional Energetic, Inc. (080459677)
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