Label: CORALITE MEDICATED HEAT- capsaicin patch
- NDC Code(s): 65923-123-01, 65923-123-02
- Packager: United Exchange Corp.
- 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 March 31, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- INDICATIONS & USAGE
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CORALITE MEDICATED HEAT
capsaicin patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-123 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 249 mg Inactive Ingredients Ingredient Name Strength LANOLIN (UNII: 7EV65EAW6H) METHYL SALICYLATE (UNII: LAV5U5022Y) NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN) PEPPERMINT OIL (UNII: AV092KU4JH) PETROLATUM (UNII: 4T6H12BN9U) ROSIN (UNII: 88S87KL877) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65923-123-01 1 in 1 POUCH 10/30/2018 1 249 in 1 PATCH; Type 0: Not a Combination Product 2 NDC:65923-123-02 2 in 1 POUCH 02/10/2016 2 249 in 1 PATCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/10/2016 Labeler - United Exchange Corp. (840130579)