Label: CALENDULA 5% SPECIAL ORDER spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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 May 8, 2018

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  • INDICATIONS & USAGE

    Directions: FOR Topical USE ONLY.

  • DOSAGE & ADMINISTRATION

    Use or as needed. Ages 12 and older: 2-3 sprays. Ages 2-11: 1-2 sprays. Under age 2: Consult a doctor.

  • ACTIVE INGREDIENT

    Active Ingredients: 100gm spray contain: 5gm Calendula 1X

  • INACTIVE INGREDIENT

    Inactive Ingredients: Distilled water, Sodium chloride, Tea tree oil, Grapefruit seed extract

  • PURPOSE

    Use: Temporary relief of headache.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • WARNINGS

    Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any
    ingredient. Consult a doctor before use for
    serious conditions or if conditions worsen or
    persist. If pregnant or nursing, consult a doctor before use. Avoid contact with eyes. Do not use if safety seals on box are broken or missing.

    SHAKE WELL BEFORE USE

  • QUESTIONS

    Questions? Call 866.642.2858
    Made with care by Uriel, East Troy, WI 53120
    www.urielpharmacy.com

  • PRINCIPAL DISPLAY PANEL

    Calendula5SOSpray

  • INGREDIENTS AND APPEARANCE
    CALENDULA 5% SPECIAL ORDER 
    calendula 5% special order spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-3215
    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 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    WATER (UNII: 059QF0KO0R)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48951-3215-230 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/01/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2009
    Labeler - Uriel Pharmacy Inc. (043471163)
    Establishment
    NameAddressID/FEIBusiness Operations
    Uriel Pharmacy Inc.043471163manufacture(48951-3215)
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