Label: TOPICAL ANALGESIC- menthol cream

  • NDC Code(s): 80986-101-01
  • Packager: Youngevity International 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 October 2, 2023

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  • Active Ingredient

    Menthol 1.4%, Purpose: Topical Analgesic

  • Purpose

    Topical Analgesic

  • Uses

    Temporary relief on minor aches and pains of sore muscles and joints associated with:

    • Backaches
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    For external use only.

  • Stop use and ask a doctor

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persists for more than 7 day or clears up and occurs again within a few days
  • When using this product

    When using this product:

    • Keep out of eyes, ears, and mouth
    • In case of contact with eyes, rinse eyes thoroughly with water
    • Do not apply to wounds or damaged skin
    • Do not bandage tightly
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children 2 years of age or older, apply to affected area no more than 3 to 4 times a day.

    children under 2 years of age, consult a doctor.

  • Other information

    Store in a cool, dry place

  • Inactive Ingredient

    Carbomer, celadrin (cetyl myristoleate, cetyl myristate, cetyl palmitaoleate, cetyl oleate, cetyl laurate), cetyl alcohol, ethylhexylglycerin, glycerin, glyceryl monostearate, myristyl alcohol, olive oil, peppermint oil, phenoxyethanol, polysorbate 20, propylene glycol, stearic acid, triethanolamine, water

  • PDP

    CM Cream LabelUltimate CM Cream Muscle and Joint Support 2 fl oz

  • INGREDIENTS AND APPEARANCE
    TOPICAL ANALGESIC 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80986-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL TALLOWATE (UNII: MVY7P518D2) 1.56 g  in 100 g
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.12 g  in 100 g
    STEARIC ACID (UNII: 4ELV7Z65AP) 3.5 g  in 100 g
    OLIVE OIL (UNII: 6UYK2W1W1E) 5 g  in 100 g
    PEPPERMINT OIL (UNII: AV092KU4JH) 0.7 g  in 100 g
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 1 g  in 100 g
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.5 g  in 100 g
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.5 g  in 100 g
    TROLAMINE (UNII: 9O3K93S3TK) 0.07 g  in 100 g
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I) 2.25 g  in 100 g
    CETYL ALCOHOL (UNII: 936JST6JCN) 2.25 g  in 100 g
    WATER (UNII: 059QF0KO0R) 72.65 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 5 g  in 100 g
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 3.5 g  in 100 g
    Product Characteristics
    Colorwhite (Cream) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80986-101-0159 g in 1 JAR; Type 0: Not a Combination Product06/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/30/2020
    Labeler - Youngevity International Inc. (078524610)
    Registrant - Creative Essences Inc (079120182)
    Establishment
    NameAddressID/FEIBusiness Operations
    Creative Essences Inc079120182manufacture(80986-101)
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