ROCAINOL TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]

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ROCAINOL TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]
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NDC 54312-825-01
Set ID 827ec7b2-3d87-47e0-a47a-966b25732c32
Category HUMAN OTC DRUG LABEL
Packager Compania Internacional de Comercio, S.A. de C.V.
Generic Name
Product Class
Product Number
Application Number PART348
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  • Drug Facts


  • Active ingredients

    Methyl salicylate 16%
    Menthol 8%

    Purpose

    External analgesic

  • Uses

    Temporary relief of minor aches and pains associated with • arthritis • simple backache • bruises • sprains

  • Warnings

    For External use only

    Do not use

    on pregnant women and children under 12 years of age unless directed by a doctor

    Do not apply

    to wounds or damaged skin
    Do not bandage tightly

    Discontinue use

    if excessive irritation of the skin develops

    Keep this and all drugs out of the reach of children.

    If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor

  • Directions

    Apply on affected area not more than 3 or 4 times daily. Adults and children 12 years of age and older. Children under 12 years of age: consult a doctor

  • Inactive ingredients

    Cetearyl alcohol, cetyl phosphate, distilled water, mineral oil, sodium borate, triethanolamine, white beeswax, white petrolatum

  • Package Labeling:

    LabelInner Package

  • INGREDIENTS AND APPEARANCE
    ROCAINOL TOPICAL ANALGESIC 
    methyl salicylate, menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54312-825
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE16 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54312-825-011 in 1 PACKAGE05/30/2019
    145 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/30/2013
    Labeler - Compania Internacional de Comercio, S.A. de C.V. (815039995)
    Establishment
    NameAddressID/FEIBusiness Operations
    Farmaqro, S.A. de C.V.588161468manufacture(54312-825)
    Establishment
    NameAddressID/FEIBusiness Operations
    Compania Internacional de Comercio, S.A.P.I. de C.V.815039995manufacture(54312-825)
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