CALENDULA OFFICINALIS (CALENDULA OFF.) TABLET [STANDARD HOMEOPATHIC COMPANY]

CALENDULA OFFICINALIS (CALENDULA OFF.) TABLET [STANDARD HOMEOPATHIC COMPANY]
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NDC 0360-0090-01
Set ID 4bbc29a8-6d89-41a7-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager STANDARD HOMEOPATHIC COMPANY
Generic Name
Product Class
Product Number
Application Number
  • SPL UNCLASSIFIED SECTION

    Made according to the Homeopathic Pharmacopoeia of the United States since 1903.

  • Warnings

    Do not use if cap band is missing or broken.

    If you are pregnant or nursing, consult a licensed beforeusing this product.

    If symptoms persist for 7 days or worsen, contact a licensed practitioner.

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

    To be used according to label indications and/or standard homeopathic indications.

  • INDICATIONS & USAGE

    MINOR CUTS OR SKIN IRRITATION

  • QUESTIONS

    800-624-9659

  • Directions

    ADULTS: Dissolve 4 tablets under tongue 4 times a day.CHILDREN: Consult healthcare professional.

  • INACTIVE INGREDIENT

    In a base of Acacia Gum and Lactose N.F.

  • ACTIVE INGREDIENT

    CALENDULA OFF. 6X

  • Principal Display Panel -- 250 Tablet Bottle Label

    STANDARD

    HOMEOPATHIC

    MADE IN THE USA SINCE 1903

    NDC # 0360-0090-01

    Homeopathic Medicine

    CALENDULA OFF.

    6X

    MINOR CUTS OR SKIN

    IRRITATION*

    *Claims based on traditional homeopathic

    practice, not accepted medical evidence.

    Not FDA evaluated.

    250 TABLETS

    label.

  • INGREDIENTS AND APPEARANCE
    CALENDULA OFFICINALIS 
    calendula off. tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0360-0090
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP6 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeROUNDSize5mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0360-0090-011 g in 1 BOTTLE, PLASTIC; 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 - STANDARD HOMEOPATHIC COMPANY (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    STANDARD HOMEOPATHIC COMPANY008316655manufacture(0360-0090) , pack(0360-0090) , label(0360-0090)

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