Label: ACTIVON ULTRA STRENGTH ARTHRITIS- menthol and histamine dihydrochloride stick

  • 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 22, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientPurpose
    Histamine Dihydrochloride 0.028%Topical Analgesic
    Menthol 4.574%Topical Analgesic
  • Uses

    • For the temporary relief of minor aches and pains of muscles and joints associated with
      • simple backache
      • arthritis
      • strains
      • bruises
      • sprains
  • Warnings

    For external use only.

    Do not use

    • otherwise than as directed
    • if you are allergic to any ingredient in this product
    • on a child 12 years of age with arthritis-like conditions
    • with a heating pad

    When using this product

    • avoid contact with eyes, wounds, mucous membranes, broken or irritated skin
    • do not share this product with anyone
    • do not bandage tightly

    Stop use and ask a doctor if

    • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
    • skin redness or excessive irritation of the skin develops

    If pregnant or breast-feeding, ask a health professional before use.

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

  • Directions

    • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily.
    • children under 12 years of age: ask a doctor
  • Other information

    Keep away from heat. Store between 15° and 30° C (59° and 86° F).

  • Inactive Ingredients

    diazoldinyl urea, ethyl alcohol, iodopropynyl butlylcarbamate, menthyl lactate, propylene glycol, sodium stearate, steareth-21, tetrasodium EDTA, triethenolamine, water

  • Questions ?

    call 1-800-379-8870, Weekdays 9AM to 5PM EST or visit us online at activ-on.com

  • SPL UNCLASSIFIED SECTION

    Dist. by Family First Pharmaceuticals, Inc., Reno, NV 89502

  • PRINCIPAL DISPLAY PANEL - 57 g Carton

    NEW
    STRONGEST
    ACTIVON® ARTHRITIS

    ACTIVON®
    Topical Analgesic

    ULTRA
    STRENGTH
    ARTHRITIS

    Powerful Pain Relief
    for Arthritis & Joint & Muscle Pain

    No-Mess

    NDC 51068-501-01
    NET WT 2 OZ (57 g)

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    ACTIVON ULTRA STRENGTH ARTHRITIS 
    menthol and histamine dihydrochloride stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51068-501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol, unspecified form (UNII: L7T10EIP3A) (Menthol, unspecified form - UNII:L7T10EIP3A) Menthol, unspecified form0.04574 g  in 1 g
    Histamine Dihydrochloride (UNII: 3POA0Q644U) (Histamine - UNII:820484N8I3) Histamine Dihydrochloride0.00028 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    alcohol (UNII: 3K9958V90M)  
    iodopropynyl butylcarbamate (UNII: 603P14DHEB)  
    menthyl lactate, (-)- (UNII: 2BF9E65L7I)  
    propylene glycol (UNII: 6DC9Q167V3)  
    sodium stearate (UNII: QU7E2XA9TG)  
    steareth-21 (UNII: 53J3F32P58)  
    Edetate Sodium (UNII: MP1J8420LU)  
    trolamine (UNII: 9O3K93S3TK)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51068-501-011 in 1 CARTON
    157 g in 1 CANISTER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34809/01/2011
    Labeler - Family First Pharmaceuticals, Inc. (832435809)
    Establishment
    NameAddressID/FEIBusiness Operations
    RNA Pharma, LLC079103999MANUFACTURE(51068-501)
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