Label: VALTRUM SOOTHING TOPICAL ANALGESIC- camphor, menthol ointment

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated May 12, 2010

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  • ACTIVE INGREDIENT

    DRUG FACTS:

    Active Ingredients                     Purpose

    Camphor 3%                           Pain Relieving

    Menthol 3%                            Pain Relieving

  • PURPOSE

    USES

    For the temporary relief of minor aches and pains of muscles and joints associated with

    rheumatism

    muscle strain

    sprains, bruises

    neck and shoulder stiffness

  • WHEN USING

    WARNINGS

    For external use only

    When using this product

    Use only as directed

    Do not get into eyes or on mucous membranes

    Do not apply to wounds or damaged skin

    Do not bandage tightly.

  • DO NOT USE

    Do not use

    in children under 8 years of age

    if pregnant or nursing

    with a heating pad or apply external heat

  • SPL UNCLASSIFIED SECTION

    Flammable: Keep away from heat and flame

  • STOP USE

    Stop use and ask doctor if:

    Skin redness or excessive irritation of the skin occurs

    Condition worsens

    Symptoms persist for more than 7 days or 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.

  • DOSAGE & ADMINISTRATION

    Directions:

    Apply directly to the affected area. Do not rub or massage. The skin will absorb quickly. Apply every 6 hours. Do not use more than 4 times daily.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Alcohol, Arnica Plant Extract, Cat's Claw Plant Extract, Chuchuhuasi Plant Extract, Devil's Claw Plant Extract, Eucalyptus Plant Extract, Frailejon Plant Extract, Glucosamine, Mango Leaf Extract, Rosemary Plant Extract, Rue Plant Extract, Sarsaparila Plant Extract, Water

  • INFORMATION FOR PATIENTS

    Other Information:

    For your protection, this bottle has an imprinted seal around the neck. Do not use if tamper evident seal is missing, broken or destroyed.

  • PRINCIPAL DISPLAY PANEL

    POWERFUL ANALGESIC

    WARRANTY SEAL - WARRANTY SEAL - WARRANTY SEAL - WARRANTY SEAL - WARRANTY SEAL

    New ROLLON

    santo remedio

    IMMEDIATE ACTION

    VALTRUM

    Soothing Topical Analgesic Ointment

    Net Wt. 3.18oz (90g)

    ALLY AGAINST PAIN - ALLY AGAINST PAIN - ALLY AGAINST PAIN - ALLY AGAINST PAIN - ALLY AGAINST PAIN -

    Distributed by Laboratorios Quantium LLC

    Miami, FL 33012    quantiumlab@gmail.com

    Manufactured by: Drogefar, C.A. Caracas,

    Venezuela, Zp 1050

    Lot:

    Exp:



    Made In the Bolivian Republic of Venezuela



    Temporary relief of minor pains associated with Muscle Strain, Neck and Shoulder Stiffness, Sprains and Rheumatism

  • PRINCIPAL DISPLAY PANEL

    ointmentlabel

  • INGREDIENTS AND APPEARANCE
    VALTRUM SOOTHING TOPICAL ANALGESIC 
    camphor, menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50786-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3 mg  in 100 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    CAT'S CLAW (UNII: 9060PRM18Q)  
    GLUCOSAMINE (UNII: N08U5BOQ1K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50786-003-0390151.47 mg in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34805/06/2010
    Labeler - Drogefar C.A. (855055810)
    Registrant - Drogefar C.A. (855055810)
    Establishment
    NameAddressID/FEIBusiness Operations
    Drogefar C.A.855055810manufacture, label
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