Label: COPPER OXIDE 0.4 ointment

  • 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 June 15, 2018

If you are a consumer or patient please visit this version.

  • INDICATIONS & USAGE

    Directions: FOR TOPICAL USE ONLY.

  • DOSAGE & ADMINISTRATION

    Apply to skin as needed. Under age 2: Consult a doctor.

  • ACTIVE INGREDIENT

    Active Ingredient: 100gm contains: 4gm Copper
    oxide 1X

  • INACTIVE INGREDIENT

    Inactive Ingredients: White petrolatum, Mineral oil

  • PURPOSE

    Use: Temporarily warms cold extremities.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • 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.

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    Copper Oxide 0.4 Ointment

  • INGREDIENTS AND APPEARANCE
    COPPER OXIDE 0.4 
    copper oxide 0.4 ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-3124
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION1 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48951-3124-560 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(48951-3124)