CALENDULA OFF. (CALENDULA OFFICINALIS FLOWERING TOP) OINTMENT [HYLAND'S]

CALENDULA OFF. (CALENDULA OFFICINALIS FLOWERING TOP) OINTMENT [HYLAND'S]
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NDC 54973-2052-1, 54973-2052-3, 54973-2052-9
Set ID 5563972b-6ea4-3c9d-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Hyland's
Generic Name
Product Class
Product Number
Application Number
  • 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)

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