Label: DCH PAIN RELIEVING- menthol 2% gel
- NDC Code(s): 72839-031-08
- 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 June 29, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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.
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- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DCH PAIN RELIEVING
menthol 2% gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72839-031 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) CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO) COPPER PIDOLATE (UNII: 497G7G1SL1) WATER (UNII: 059QF0KO0R) 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:72839-031-08 227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/12/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/12/2021 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(72839-031)