DCH COOLING PAIN RELIEF- menthol 10.5% spray

DCH Cooling Pain Relief by

Drug Labeling and Warnings

DCH Cooling 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

Menthol 10.5%

PURPOSE

Topical Analgesic

INDICATIONS & USAGE

For the temporary relief of minor aches and pain associated with arthritis, simple backache, muscle strains, bruises, sprains, and cramps.

WARNINGS

For external use only. Flammable--Keep away from fire or flame. When using this product avoid contact with eyes. In case of contact with eyes, flush thoroughly with water, do not apply to wounds or damaged skin, and do not bandage tightly, do not use with a heating pad. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F. . Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

INACTIVE INGREDIENT

Alcohol Denat., Arnica Montana Flower Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Dimethyl Sulfone, Echinacea Angustifolia Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DCH COOLING PAIN RELIEF 
menthol 10.5% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72839-639
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ECHINACEA ANGUSTIFOLIA LEAF (UNII: FS7G8S6PJ8)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
JUNIPER BERRY (UNII: O84B5194RL)
CHAMOMILE (UNII: FGL3685T2X)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
WATER (UNII: 059QF0KO0R)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72839-639-03	85 g in 1 CAN; Type 0: Not a Combination Product	05/24/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/24/2021

Labeler - Derma Care Research Labs, LLC (116817470)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs, LLC		116817470	manufacture(72839-639)