DCH LABS COOL AND HEAT ROLL-ON- menthol 16% liquid

DCH Labs Cool and Heat Roll-On by

Drug Labeling and Warnings

DCH Labs Cool and Heat Roll-On 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 16%

PURPOSE

External Analgesic

INDICATIONS & USAGE

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

WARNINGS

For external use only. Flammable--Keep away from fire or flame. When using this product avoid contact with eyes, do not apply to wounds or damaged skin, and do not bandage tightly. 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

Clean affected area before applying product. 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 old ask a doctor.

INACTIVE INGREDIENT

Acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., glycerin, phenoxyethanol, propylene glycol, water, xanthan gum.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DCH LABS COOL AND HEAT ROLL-ON 
menthol 16% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72839-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	16 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72839-101-02	71 g in 1 BOTTLE; Type 0: Not a Combination Product	12/16/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/16/2021

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(72839-101)