PAIN RELIEF COPPERGEL- camphor 3.5%, menthol 3.5% spray

Pain Relief by

Drug Labeling and Warnings

Pain Relief by is a Otc medication manufactured, distributed, or labeled by Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Camphor 3.5%, Menthol 3.5%

PURPOSE

Topical Analgesic

DOSAGE & ADMINISTRATION

For the temporary relief of itching associated with minor aches and pains in muscles and joints associated with strains, sprains, arthritis, and bruises.

WARNINGS

For external use only.

Flammable--Do not use while smoking or near heat or flame.

When using this product keep out of eyes, do not apply to wounds or damaged skin, do not bandage tightly.

Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days if symptoms clear up and occur again within a few days, or if redness or irritation develops.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

Clean the affected area before applying products. Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor.

INACTIVE INGREDIENT

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Blue 1, Copper PCA, Ethyhexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Isopropyl Alcohol, Phenoxyethanol, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEF  COPPERGEL
camphor 3.5%, menthol 3.5% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72839-253
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	1 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
COPPER PIDOLATE (UNII: 497G7G1SL1)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72839-253-03	1 in 1 CARTON	06/27/2019
1		89 mL in 1 BOTTLE; 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	06/14/2019

Labeler - Derma Care Research Labs, LLC (116817470)