Label: CORALITE EXTRA STRENGTH PAIN RELIEF SLEEVE KNEE- menthol patch
- NDC Code(s): 65923-121-01
- 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 March 31, 2022
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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
- adults and children 12 years of age and older:
- open pouch and remove sleeve
- remove plastic insert and discard
- pull sleeve onto knee, large ankles or elbows until the colored (medicated) section of the sleeve is positioned directly over the affected area. Sleeve should feel snug, but not tight. Note: the drawings should help you understand how to do this.
- apply one sleeve to affected area no more than 3 times daily
- do not wear sleeve for more than 8 hours
- children under 12 years of age: consult a doctor
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CORALITE EXTRA STRENGTH PAIN RELIEF SLEEVE KNEE
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-121 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 336 mg Inactive Ingredients Ingredient Name Strength TROLAMINE (UNII: 9O3K93S3TK) CARBOMER 940 (UNII: 4Q93RCW27E) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) ETHYLPARABEN (UNII: 14255EXE39) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65923-121-01 1 in 1 BOX 02/10/2016 1 1 in 1 POUCH; 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)