Label: ANALGESIC GEL DR. COLLADO MENTHOL 4 METHYL SALICYLATE- menthol, methyl salicylate ointment

  • NDC Code(s): 42333-000-01
  • Packager: Laboratorios Dr. Collado, S.A.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 29, 2024

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  • Drug Facts

  • Active ingredients

    Menthol 4%Methyl Salicylate 10%

    Purpose

    External Analgesic

  • Use

    For the temporary relief of minor aches and pains of muscles and joints.

  • Warnings

    For external use only.

    Do not use

    • on wounds or damaged skin

    When using this product

    • avoid contact with eyes
    • 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.

    Keep out of reach of children.

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

  • Directions

    Audlts and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 yeas of age: Do not use, consult a doctor.

  • Other information

    • Store in a clean dry place at temperatures less than 86°F (30°C)
  • Inactive ingredients

    Camphor, Carbomer, Cetrimonium Chloride, Cetyl Alcohol, Ethyl Alcohol, Eucalyptus Globulus Leaf Oil, FD&C Blue No.1, Purified Water, Triethanolamine.

  • Questions or Comments?

    +1 809-338-7361

  • Package Labeling:

    Label
  • INGREDIENTS AND APPEARANCE
    ANALGESIC GEL DR. COLLADO MENTHOL 4 METHYL SALICYLATE 
    menthol, methyl salicylate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42333-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALCOHOL (UNII: 3K9958V90M)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42333-000-01227 g in 1 TUBE; Type 0: Not a Combination Product02/02/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/02/2024
    Labeler - Laboratorios Dr. Collado, S.A. (817468001)
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