Label: ARTHRITIS RELIEF- 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 February 28, 2014

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  • ACTIVE INGREDIENT

    Active Ingredient

    Menthol 1.25%

  • PURPOSE

    Purpose

    Topical Analgesic

  • INDICATIONS & USAGE

    Use   Temporarily relieves minor aches and pains of muscles and joints associated with:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • DOSAGE & ADMINISTRATION

    Directions

    • Adult and children 12 years of age or older: Apply to affected area not more than 3 to 4 times daily.
    • Children under 12 years of age: Consult a physician.
  • INACTIVE INGREDIENT

    Inactive Ingredients: aloe vera gel, cetyl alcohol, cetyl esters (proprietary blend of esterfied fatty acids), cinnamon oil, eucalyptus oil, glyceryl stearate, grape seed oil, hypromellose, jojoba oil, peppermint oil, phenoxyethanol, potassium sorbate, purified water, sodium benzoate, squalane, stearic acid, stearyl alcohol, tea tree oil, vegetable glycerin, wintergreen oil.

  • QUESTIONS

    Questions?1-800-895-2108

    Reorder Code: G650K2BT

    Manufactured for and Distributed by NewMarket Health

    Products, LLC. 702 Cathedral St. Baltimore, MD 21201

    Made in the USA from foreign and domestic ingredients.

    650SAC2

    LR-Q2

  • WARNINGS

    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

    Keep out of reach of children.
    If swallowed, get medical help or contact a Poison Control Center right away.

  • PRINCIPAL DISPLAY PANEL

    North Star

    Nutritionals

    PARABEN FREE!

    Arthritis

    Relief

    Cream

    Pain Relieving Cream

    with Menthol

    Net Wt. 2 oz (57g)

    Arthritis Relief Label 57g

  • INGREDIENTS AND APPEARANCE
    ARTHRITIS RELIEF 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50972-273
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL12.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    JOJOBA OIL (UNII: 724GKU717M)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SQUALANE (UNII: GW89575KF9)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50972-273-0157 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/01/2013
    Labeler - NewMarket Health Products LLC (828825989)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alera Technologies, Inc.962055740manufacture(50972-273)
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