DCH COOLING PAIN RELIEF- menthol 4% gel 
Derma Care Research Labs, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DCH Cooling Pain Relief Gel, Menthol 4%

Menthol 4%

Topical Analgesic

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

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.

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

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

Label

DCH COOLING PAIN RELIEF 
menthol 4% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-297
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72839-297-0389 mL in 1 TUBE; Type 0: Not a Combination Product11/11/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/11/2022
Labeler - Derma Care Research Labs, LLC (116817470)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs, LLC116817470manufacture(72839-297)

Revised: 7/2023
Document Id: 00ed3175-c3b9-6545-e063-6394a90acfd1
Set id: 00ed3175-c3ba-6545-e063-6394a90acfd1
Version: 1
Effective Time: 20230720
 
Derma Care Research Labs, LLC