Label: CORALITE COLD AND HOT- menthol patch
- NDC Code(s): 65923-214-01
- 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 September 26, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
Directions
- open pouch and remove patch
- carefully peel off protective backing and apply sticky side to affected area
- adults and children 12 years of age and older:
- do not wear patch for more than 8 hours
- apply to affected area no more than 3 times daily
- children under 12 years of age: consult a doctor
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CORALITE COLD AND HOT
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-214 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 210 mg Inactive Ingredients Ingredient Name Strength STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (UNII: K7S96QM8DV) LANOLIN (UNII: 7EV65EAW6H) NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ZINC OXIDE (UNII: SOI2LOH54Z) POLYISOBUTYLENE (85000 MW) (UNII: 7X53O5S2ZY) ALUMINUM SILICATE (UNII: T1FAD4SS2M) GLYCERYL ROSINATE (UNII: SD112V492J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65923-214-01 1 in 1 POUCH; Type 0: Not a Combination Product 09/26/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/26/2023 Labeler - United Exchange Corp. (840130579)