Label: ARNICA DE LA ABUELA- heterotheca inuloides cass, wintergreen, balsam of peru ointment

  • NDC Code(s): 60854-001-01, 60854-001-02
  • Packager: LABORATORIOS BREMER, S.A.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 30, 2023

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  • ACTIVE INGREDIENT

    Gaultheria Procumbens (Wintergreen Oil) 0,05 Oz.

    Myroxylon Pareirae (Balsam of Peru)  0,03 Oz

    Helerotheca Inuloides Cass (Arnica Ext. Fluid)  0,02 Oz

  • PURPOSE

    Analgesic in the treatment of muscle pain

  • DOSAGE & ADMINISTRATION

    Dose and use way: Apply 2 or 3 times a day on the affected area

  • WARNINGS

    Contraindications: Hypersensitivity to the formula ingredients.

    If the problem persist consult your doctor. Secondary reactions. In

    case of skin irritations suspend this product use.

    Warning:  Arnica (Extract) can be toxic if ingested

    Wintergreen Oil can be toxic if ingested

    For external use only

  • PREGNANCY OR BREAST FEEDING

    Pregnancy or nursing baby:  Yes, this product apply

    on pregnancy and nursing women.

  • KEEP OUT OF REACH OF CHILDREN

    Caution: Keep out the reach of the children.

  • INDICATIONS & USAGE

    Indications: Analgesic in the treatment of muscle pain

  • INACTIVE INGREDIENT

    Excipient (Petrolatum and Parafin) Q.S. 3.52 Oz

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    ARNICA DE LA ABUELA 
    heterotheca inuloides cass, wintergreen, balsam of peru ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60854-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HETEROTHECA INULOIDES FLOWER (UNII: W9NZ9OZF68) (HETEROTHECA INULOIDES FLOWER - UNII:W9NZ9OZF68) HETEROTHECA INULOIDES FLOWER0.59 g  in 104 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE1.48 g  in 104 mL
    BALSAM PERU (UNII: 8P5F881OCY) (BALSAM PERU - UNII:8P5F881OCY) BALSAM PERU0.88 g  in 104 mL
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60854-001-0144 mL in 1 CAN; Type 0: Not a Combination Product01/01/2016
    2NDC:60854-001-0231 mL in 1 CAN; Type 0: Not a Combination Product01/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/01/2016
    Labeler - LABORATORIOS BREMER, S.A. (811585264)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABORATORIOS BREMER, S.A.811585264manufacture(60854-001)
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