CALENDULA 5% SPECIAL ORDER SPRAY [URIEL PHARMACY INC.]

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  • CALENDULA 5% SPECIAL ORDER SPRAY [URIEL PHARMACY INC.]

CALENDULA 5% SPECIAL ORDER SPRAY [URIEL PHARMACY INC.]
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NDC 48951-3215-2
Set ID 6bb46614-a14c-a3dd-e053-2a91aa0a11c4
Category HUMAN OTC DRUG LABEL
Packager Uriel Pharmacy Inc.
Generic Name
Product Class
Product Number
Application Number
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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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