Label: VALTRUM US SOOTHING TOPICAL ANALGESIC (camphor- synthetic, menthol ointment

  • 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 September 23, 2020

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  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredients

    Camphor 3%                         

    Menthol 3%                           

  • PURPOSE

    PurposePain Relieving

  • INDICATIONS & USAGE

    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
  • WARNINGS

    WARNINGS

    For external use only


  • WHEN USING

    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
  • STORAGE AND HANDLING

    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, Carbopol, Cat's Claw Plant Extract, Devil's Claw Plant Extract,  Chuchuhuasi Plant Extract, Glucosamine, Methyl Salicilate, Triethanolamina, Water

  • SPL UNCLASSIFIED SECTION

    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 US

    Soothing Topical Analgesic Ointment

    Net Wt. 3.18oz (90g)

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

    Temporary relief of minor pains associated with Muscle Strain, Neck and Shoulder Stiffness, Sprains and Rheumatism
    MADE BY: Laboratorios Quantium, LLC.
    Exclusively Distributed For USA BY:
    QUANTIUMMED DISTRIBUTORS, INC.
    MIAMI - FLORIDA - 33172
    TELF: 305-514-9718 AND 786-2508995
    email: QUANTIUMMED GMAIL.COM
    QUANTIUMLAB GMAIL.COM

  • Label

    Valtrum

  • INGREDIENTS AND APPEARANCE
    VALTRUM US SOOTHING TOPICAL ANALGESIC 
    camphor (synthetic), menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75849-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    CAT'S CLAW (UNII: 9060PRM18Q)  
    HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
    GLUCOSAMINE (UNII: N08U5BOQ1K)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75849-100-0090 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product03/09/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/09/2011
    Labeler - Laboratorios Quantium LLC (027101451)
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