DERMACHANGE COLD THERAPY- menthol gel

Dermachange Cold Therapy by

Drug Labeling and Warnings

Dermachange Cold Therapy by is a Otc medication manufactured, distributed, or labeled by Private Label Beauty and Wellness, Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 2%

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.

Do not use with other topical pain relievers, with heating pad or heating devices.

When using this product do not use in or near the eyes, do not apply to wounds or damaged skin, do not bandage tightly.

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

Ammonium hydroxide, blue 1, carbomer, copper PCA, isopropyl alcohol, magnesium sulfate, sodium hydroxide, thymol, water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMACHANGE COLD THERAPY 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83520-131
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
AMMONIA (UNII: 5138Q19F1X)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)
COPPER PIDOLATE (UNII: 497G7G1SL1)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
THYMOL (UNII: 3J50XA376E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83520-131-08	227 g in 1 JAR; Type 0: Not a Combination Product	10/27/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/27/2023

Labeler - Private Label Beauty and Wellness (035014854)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs, LLC		116817470	manufacture(83520-131)