Label: ROSE COPPER ointment
- NDC Code(s): 48951-8348-5
- Packager: Uriel Pharmacy Inc.
- 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 12, 2024
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- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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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
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INGREDIENTS AND APPEARANCE
ROSE COPPER
rose copper ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48951-8348 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CUPROUS OXIDE (UNII: T8BEA5064F) (CUPROUS OXIDE - UNII:T8BEA5064F) CUPROUS OXIDE 1 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) MINERAL OIL (UNII: T5L8T28FGP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG) ROSE OIL (UNII: WUB68Y35M7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48951-8348-5 60 g in 1 TUBE; Type 0: Not a Combination Product 09/01/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/01/2009 Labeler - Uriel Pharmacy Inc. (043471163) Establishment Name Address ID/FEI Business Operations Uriel Pharmacy Inc. 043471163 manufacture(48951-8348)