FDA.reportPublic FDA data

Rose Copper

Manufacturer
Uriel Pharmacy Inc.
Effective date
2025-01-07
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:30:07

Label at a glance#

ProductRose Copper
Active ingredientCUPROUS OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR TOPICAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

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

OTC - ACTIVE INGREDIENT SECTION

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

INACTIVE INGREDIENT SECTION

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

Prepared using rhythmical processes.

OTC - PURPOSE SECTION

Uses: Temporarily warms cold extremities and eases muscle cramps.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

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, 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 SECTION

Questions? Call 866.642.2858 Made with care by Uriel, East Troy, WI 53120 shopuriel.com Lot:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rose Copper OintmentRose Copper Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-8348-5Rose Copper60 g in 1 TUBEOINTMENT607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-8348ROSE COPPER OINTMENT [URIEL PHARMACY INC.]7Current NDC, Legacy NDC, 1 package rows20250109_6749923f-e896-496f-a8ff-7cf7a386b524.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CUPRIC CATIONACTIVE INGREDIENT8CBV67279L1
CUPRIC CATIONACTIVE MOIETY8CBV67279L1
GERANIUM OIL, ALGERIAN TYPEINACTIVE INGREDIENT5Q1I94P4WG1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U1
ROSE OILINACTIVE INGREDIENTWUB68Y35M71
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-834848951-8348-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
MINERAL OILT5L8T28FGPIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
GERANIUM OIL, ALGERIAN TYPE5Q1I94P4WGIACT
ROSE OILWUB68Y35M7IACT
CUPROUS OXIDET8BEA5064FACTIM

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route
2 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rose CopperROSE COPPERUriel Pharmacy Inc.6749923f-e896-496f-a8ff-7cf7a386b5242025-01-07WarningsExact identifier
ndc (package): 48951-8348-5
ndc (product): 48951-8348
ndc11 (package): 48951834805
spl id: 2b247a51-97b4-e240-e063-6294a90a8907
spl set id: 6749923f-e896-496f-a8ff-7cf7a386b524

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.