Label: CELADRIN- menthol cream

  • 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, 2010

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  • Active Ingredient

    Menthol 1.5%

  • Purpose

    Pain relieving cream
  • Use

    Temporarily relieves minor aches and pains of muscles
    and joints associated with:
    simple backache
    arthritis
    strains
    bruises
    sprains
  • Warnings

    For external use only

  • Do not use

    on wounds or damaged skin
  • When using this product

    • avoid contact with eyes or mucous membranes
    • do not bandage tightly
  • Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
  • Keep out of reach of children


  • Directions

    • Adult and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
    • Children under 2 years of age: consult a physician.
  • Inactive Ingredients

    aloe vera gel, celadrin® proprietary blend of esterified fatty acids (7.5%), cetyl alcohol, cinnamon oil, eucalyptus oil, glyceryl stearate, grape seed oil, hypromellose, jojoba oil, peppermint oil, potassium sorbate, purified water, squalane, stearic acid, stearyl alcohol, tea tree oil, vegetable glycerin, wintergreen oil.
  • PRINCIPAL DISPLAY PANEL

    Image of the principal display panel
    image of principal panel


  • INGREDIENTS AND APPEARANCE
    CELADRIN 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31586-2683
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYPROMELLOSE (UNII: 3NXW29V3WO)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SQUALANE (UNII: GW89575KF9)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:31586-2683-157 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/30/2007
    Labeler - Natural Factors Nutritional Products Ltd (205628329)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natural Factors Nutritional Products Ltd 205628329manufacture
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