Label: AMBER AMETHYST cream

  • 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 December 11, 2018

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  • INDICATIONS & USAGE

    Directions: FOR TOPICAL USE ONLY.

  • DOSAGE & ADMINISTRATION

    Apply to skin on and around the neck and jaw area as needed. Under age 2: Consult a doctor.

  • ACTIVE INGREDIENT

    Active Ingredients: 100 gm contains: 4 gm Aesculus (Horse chestnut) 2X, 4 gm Equisetum (Common horsetail) 2X; Amber (Fossilized tree resin) 3X, Amethyst (Nat. silicic acid anhydrate with traces of manganese and iron) 6X

  • INACTIVE INGREDIENT

    Inactive Ingredients: Peat extract, Distilled water, Stearic acid, Isopropyl myristate, Lavender oil, Cetyl alcohol, Polyoxyl 40 stearate, Stearyl alcohol, Xanthan gum, Sorbic acid, Tea tree oil, Frankincense oil, Myrrh oil, Grapefruit seed extract

  • PURPOSE

    Use: Temporary relief of teething pain.

  • WARNINGS

    Warnings: FOR EXTERNAL USE ONLY.
    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, if conditions worsen or persist, or accidental ingestion occurs. If pregnant or nursing, consult a doctor before use. Avoid contact with eyes. Do not use if safety seal is broken or missing.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    Amber Amethyst Cream

  • INGREDIENTS AND APPEARANCE
    AMBER AMETHYST 
    amber amethyst cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-1270
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT2 [hp_X]  in 1 g
    EQUISETUM ARVENSE TOP (UNII: 1DP6Y6B65Z) (EQUISETUM ARVENSE TOP - UNII:1DP6Y6B65Z) EQUISETUM ARVENSE TOP2 [hp_X]  in 1 g
    AMBER (UNII: 70J9Z0J26P) (AMBER - UNII:70J9Z0J26P) AMBER3 [hp_X]  in 1 g
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE6 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TEA TREE OIL (UNII: VIF565UC2G)  
    SPHAGNUM SQUARROSUM PEAT (UNII: Z7G226H5SA)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SORBIC ACID (UNII: X045WJ989B)  
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    MYRRH OIL (UNII: H74221J5J4)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48951-1270-560 g in 1 TUBE; 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(48951-1270)
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