Label: CORALITE BLUE ICE- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 65923-157-27 - 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 October 5, 2016
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- DO NOT USE
- 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
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INGREDIENTS AND APPEARANCE
CORALITE BLUE ICE
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-157 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL .02 g in 1 g Inactive Ingredients Ingredient Name Strength AMMONIA (UNII: 5138Q19F1X) CARBOMER 940 (UNII: 4Q93RCW27E) CUPRIC SULFATE (UNII: LRX7AJ16DT) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ISOPROPYL ALCOHOL (UNII: ND2M416302) MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) THYMOL (UNII: 3J50XA376E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65923-157-27 227 g in 1 JAR; Type 0: Not a Combination Product 10/05/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/05/2016 Labeler - United Exchange Corp. (840130579)