Other
DRUG FACTS:
Distributed By: Copper Relief, LLC
Wayzata, MN 55391
www.coppergel.com
MADE IN THE USA
Coppergel
FDA Label NDC 72081-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Copperrelief, Llc for the product Coppergel (NDC 72081-001). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
ACTIVE INGREDIENTS:
Camphor 3.5%
Menthol 3.5%
Otc - Purpose
Purpose:
Topical Analgesic
Indications & Usage
USES: for the temporary relief of minor aches and pains in muscles and joints associated with:
- strains
- sprains
- sports injuries
- arthritis
- bruises
Warnings
WARNINGS:
For external use only.
Otc - Do Not Use
Do not use
- with other topical pain relievers
- with heating pads or heating devices
Otc - When Using
When using this product
- do not get into eyes
- do not apply to wounds or damaged skin
- do not bandage tightly
Otc - Stop Use
Stop use and ask a doctor if
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days
- redness or irritation develops
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
DIRECTIONS:
- clean the affected area before applying product
- adults and children 2 years of age and older: apply to affected not more than 3 to 4 times daily
Inactive Ingredient
INACTIVE INGREDIENTS: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Blue 1, Copper PCA, Ethylhexylglycerin, Eucalyptus Globulus (Eucalyptus) Leaf Oil, Isopropyl Alcohol, Phenoxyethanol, Triethanolamine, Water (Aqua)
Package Label.Principal Display Panel
CopperGel
KNOCK OUT THE PAIN™
Topical Analgesic Gel
NET WT. 3 OZ (85g)
* Please review the disclaimer below.
