Label: CALENDULA OFF.- calendula officinalis flowering top ointment

  • NDC Code(s): 54973-2052-1, 54973-2052-3, 54973-2052-9
  • Packager: Hyland's
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated July 28, 2017

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  • INDICATIONS & USAGE

    Minor Skin Irritations

  • Warnings

    For External Use Only.

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

    If symptoms persist for more than seven days or worsen, consults a licensed health care professional.

    Do not use if tamper evident seal is broken or missing.

  • Directions

    Wash affected area with lukewarm water and apply freely as needed, or as recommended by a licensed health care provider.

  • INACTIVE INGREDIENT

    In a base of Petrolatum USP, with 5% Lanolin USP.

  • QUESTIONS

    800/624-9659

  • ACTIVE INGREDIENT

    CALENDULA OFFICINALIS 1x

  • PURPOSE

    For the temporary symptomatic relief of skin irritations due to sunburn, windburn and chafing or diaper rash. Promotes healing of minor cuts and abrasions of the skin.

  • PRINCIPAL DISPLAY PANEL

    NDC 54973-2052-09

    Hyland's™

    HOMEOPATHIC

    Calendula

    Off. 1x

    Minor Skin Irritations

    Homeopathic Ointment

    13.5 OZ./405 GM.

    1

  • INGREDIENTS AND APPEARANCE
    CALENDULA OFF. 
    calendula officinalis flowering top ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-2052
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    Coloryellow (Greenish-yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-2052-9405 g in 1 JAR; Type 0: Not a Combination Product02/17/1997
    2NDC:54973-2052-3105 g in 1 JAR; Type 0: Not a Combination Product02/17/1997
    3NDC:54973-2052-130 g in 1 TUBE; Type 0: Not a Combination Product02/17/1997
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/17/1997
    Labeler - Hyland's (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(54973-2052) , pack(54973-2052) , label(54973-2052)