DCH COOLING PAIN RELIEF- menthol 4% gel

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 4%

PURPOSE

Topical Analgesic

INDICATIONS & USAGE

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

WARNINGS

For external use only.

When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin, do not bandage tightly, and do not use with heating pad.

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear and occur again within a few days.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

adults and children 12 years and older, apply to affected area not more than 3 to 4 times daily. Children under 12 years old, ask a doctor

INACTIVE INGREDIENT

Blue 1, carbomer, isopropyl alcohol, magnesium sulfate, sodium hydroxide, water, yellow 5.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DCH COOLING PAIN RELIEF 
menthol 4% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72839-297
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)
WATER (UNII: 059QF0KO0R)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72839-297-03	89 mL in 1 TUBE; Type 0: Not a Combination Product	11/11/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/11/2022

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(72839-297)