Label: VALTRUM ANALGESIC (camphor- synthetic, menthol, menthyl salicylate gel

  • 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 August 19, 2021

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  • Drug Facts

  • Active Ingredients

    Camphor 3%
    Menthol 3%
    Menthyl salicilate 10%

    Purpose

    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

    • Avoid contact with eyes and mucous membranes
    • Do not use otherwise than as directed.

    Caution: Discontinue use if excessive irritation of the skin develops.

    When using this product:

    • Do not bandage tightly
    • Do not apply to wounds or damaged skin.

    Stop use and ask a doctor if:

    • Conditions worsens
    • Symptoms persist for more than 7 days or clear up and occur again within a few days.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

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

  • Directions

    Adults and Children 18 years of age and older: Apply to affected area not more than 3 to 4 times daily.  Children under 18 years of age: Consult a doctor.

  • Other information

    • Store in a cool dry place away from direct sunlight
    • Keep lid tightly closed
  • Inactive Ingredients:

    Arnica Montana Extract, Carbopol 940, Cat's Claw Extract, Chuchuhuasi Extract, Devil's Claw Extract, Glucosamine Sulfate, Isopropil Alcohol, Peg 40 Castor Oil, Purified Water, Triethanolamine.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    VALTRUM ANALGESIC 
    camphor (synthetic), menthol, menthyl salicylate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75849-312
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)30 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL30 mg  in 1 g
    MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD) (SALICYLIC ACID - UNII:O414PZ4LPZ) MENTHYL SALICYLATE, (+/-)-100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CAT'S CLAW (UNII: 9060PRM18Q)  
    MAYTENUS KRUKOVII BARK (UNII: K50SD0PDVR)  
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75849-312-0390 g in 1 TUBE; Type 0: Not a Combination Product07/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/15/2021
    Labeler - Laboratorios Quantium LLC (027101451)
    Establishment
    NameAddressID/FEIBusiness Operations
    GADAL Laboratories, Inc841305639manufacture(75849-312) , label(75849-312) , pack(75849-312)
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