Label: ARTHRI-SUPPORT- 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 December 18, 2013

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  • Active Ingredients


    Menthol 5%

  • Purpose

    Menthol 5%.......................................Topical Analgesic

  • Uses

    For temporary relief of minor aches and pains
    associated with arthritis, backaches, sprains, bruises,
    strains, and stiffness.

  • Warnings

    • For external use only.
    • Use only as directed.
    • Avoid contact with eyes and mucous membranes.

    Do not apply to open wounds or damaged skin.

     KEEP OUT OF REACH OF CHILDREN

    – if swallowed get medical help or contact a poison
    center right away. • Do not bandage tightly or use
    with heating pads.

    Consult a physician before use for children under 12 or if; pregnant or nursing;
    condition persists more than seven days or clears
    up and returns within seven days; excessive skin
    irritation occurs; you are prone to allergic
    reactions to salicylates, including aspirin.

  • Directions

    • Adults and children under 12 years of age and older: apply to affected area
    no more than 3 to 4 times daily.
    • Children under 12: consult a physician.
    • Apply generously and massage into affected areas
    until completely absorbed.
    • Apply before and after sports or exercise to help soothe aching muscles, muscle strain, and stiffness.

    Repeat as needed up to four times a day.

  • Other Information

    Store at 20º to 25º C (68º to 77º F)

  • Inactive Ingredients

    Water, Methyl Glucose Sesquistearate, Arthri-Support
    Cream Proprietary Herbal Extract Blend,
    Natural Oil of Wintergreen (Gaultheria procumbens), Avocado Oil (Persea
    gratissima), Stearic Acid, Aloe (Aloe barbadensis), Grape Seed Oil (Vitis
    vinifera), Cyclomethicone, Shea Butter (Butyrospermum parkii). Steareth-10,
    Phenoxyethanol Methylparaben, Ceteareth-20, Steareth-2.

  • Questions/comments?

    714-639-0343 Manufactured for: Pure Science Int.,
    Mission Viejo, CA 92692

  • Principal Display Panel


    PURE
    SCIENCE
    INTERNATIONAL

    ARTHRI
    SUPPORT

    FAST AND LASTING
    PAIN REFLIEF!

    Supports Joint and
    Muscle Comfort

    MEDICATED CREAM
    net weight 3.0 oz. (85g)

    Arthri Support Label


  • INGREDIENTS AND APPEARANCE
    ARTHRI-SUPPORT  
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43078-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GAULTHERIA PROCUMBENS TOP (UNII: 830295X963)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    STEARETH-10 (UNII: FD0913P475)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    STEARETH-2 (UNII: V56DFE46J5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43078-001-3085 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/01/2007
    Labeler - Pure Science International, Inc. (078532055)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, Inc.969241041manufacture(43078-001)
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