COPPERGEL- camphor, menthol gel

CopperGel by

Drug Labeling and Warnings

CopperGel by is a Otc medication manufactured, distributed, or labeled by CopperRelief, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS:

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:

Camphor 3.5%

Menthol 3.5%

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.

DO NOT USE

Do not use

• with other topical pain relievers
• with heating pads or heating devices

WHEN USING

When using this product

• do not get into eyes
• do not apply to wounds or damaged skin
• do not bandage tightly

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

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)

SPL UNCLASSIFIED SECTION

Distributed By: Copper Relief, LLC

Wayzata, MN 55391

www.coppergel.com

MADE IN THE USA

PRINCIPAL DISPLAY PANEL

CopperGel

KNOCK OUT THE PAIN™
Topical Analgesic Gel

NET WT. 3 OZ (85g)

INGREDIENTS AND APPEARANCE

COPPERGEL 
camphor, menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72081-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.5 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	3.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
COPPER PIDOLATE (UNII: 497G7G1SL1)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72081-001-03	1 in 1 CARTON	02/05/2018
1		85 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/05/2018

Labeler - CopperRelief, LLC (080979585)