Label: CORALITE PAIN RELIEF- camphor, menthol, methyl salicylate patch
- NDC Code(s): 65923-564-20
- 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 May 12, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CORALITE PAIN RELIEF
camphor, menthol, methyl salicylate patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-564 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 1.2 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5.7 g in 100 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 6.3 g in 100 g Inactive Ingredients Ingredient Name Strength LANOLIN (UNII: 7EV65EAW6H) NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN) PETROLATUM (UNII: 4T6H12BN9U) ZINC OXIDE (UNII: SOI2LOH54Z) POLYISOBUTYLENE (800000 MW) (UNII: Y132ZOQ9H7) GLYCERYL ROSINATE (UNII: SD112V492J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65923-564-20 20 in 1 PACKAGE 04/12/2018 1 1 g 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 04/12/2016 Labeler - United Exchange Corp. (840130579)