DERMACHANGE COLD THERAPY- menthol gel 
Private Label Beauty and Wellness

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Dermachange Cold Therapy Gel, Menthol 2%

Menthol 2%

Topical Analgesic

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

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.

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

• 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

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

Label

DERMACHANGE COLD THERAPY 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83520-131
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83520-131-08227 g in 1 JAR; Type 0: Not a Combination Product10/27/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01710/27/2023
Labeler - Private Label Beauty and Wellness (035014854)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs, LLC116817470manufacture(83520-131)

Revised: 3/2024
Document Id: 12ef7dd8-3da2-9c87-e063-6394a90ac924
Set id: 12ef7dd8-3da3-9c87-e063-6394a90ac924
Version: 1
Effective Time: 20240305
 
Private Label Beauty and Wellness