Label: VALTRUM SOOTHING TOPICAL ANALGESIC (camphor- synthetic, menthol, methyl salicylate 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 28, 2020

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  • Drug Facts

  • Active Ingredients

    Camphor 2,5%

    Menthol 2,5%

    Methyl Salicilate 10%

    Purpose

    Pain Relieving

  • 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

    • 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

    • in children under 8 years of age.
    • if pregnant or nursing.
    • with heating pad or apply external heat.

    Flammable:

    • Keep away from heat and flame.

    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 the reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • 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 ingredients:

    Alcohol, Arnica Plant Extract, Carbopol, Cat's Claw Plant Extract, Devil's Claw Plant Extract, Chuchuhuasi Plant Extract, Glucosamine, Trietanolamina, water.

  • 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.

  • Package Labeling:

    label

  • INGREDIENTS AND APPEARANCE
    VALTRUM SOOTHING TOPICAL ANALGESIC 
    camphor (synthetic), menthol, methyl salicylate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75849-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)25 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL25 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
    GLUCOSAMINE (UNII: N08U5BOQ1K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75849-300-001 in 1 CARTON11/12/2015
    190 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/12/2015
    Labeler - Laboratorios Quantium LLC (027101451)
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