Label: DCH COOLING PAIN RELIEF- menthol 4% gel
- NDC Code(s): 72839-297-03
- Packager: Derma Care Research Labs, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 20, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DCH COOLING PAIN RELIEF
menthol 4% gelProduct 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)