Rose Copper Ointment
FDA Label NDC 48951-8348

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Uriel Pharmacy Inc. for the product Rose Copper (NDC 48951-8348). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding indications & usage, dosage & administration, otc - active ingredient, inactive ingredient, otc - purpose, otc - keep out of reach of children, warnings, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Indications & Usage

Directions: FOR TOPICAL USE ONLY.

Dosage & Administration

Apply to hands and feet as needed. For muscle cramps, massage into skin as needed. Under age 2: Consult a doctor.

Otc - Active Ingredient

Active Ingredient: 100 gm contains: 4gm Cuprum oxydulatum (Copper oxide) 1X

Inactive Ingredient

Inactive Ingredients: White petrolatum, Mineral oil, Silica, Geranium oil, Rose oil

Otc - Purpose

Uses: Temporarily warms cold extremities and eases muscle cramps.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Warnings

Warnings: FOR EXTERNAL USE ONLY. 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.

Otc - Questions

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

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