Label: MIRACLE ICE ULTRA STRENGTH (menthol and camphor- synthetic gel
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Contains inactivated NDC Code(s)
NDC Code(s): 60691-116-30 - Packager: FDN Enterprises,LLC
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated September 20, 2013
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 227 g Jar Label
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INGREDIENTS AND APPEARANCE
MIRACLE ICE ULTRA STRENGTH
menthol and camphor (synthetic) gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60691-116 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 1 g in 100 g Camphor (synthetic) (UNII: 5TJD82A1ET) (Camphor (synthetic) - UNII:5TJD82A1ET) Camphor (synthetic) 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Propylene Glycol (UNII: 6DC9Q167V3) Methyl Salicylate (UNII: LAV5U5022Y) Sodium Hydroxide (UNII: 55X04QC32I) Methylparaben Sodium (UNII: CR6K9C2NHK) Propylparaben Sodium (UNII: 625NNB0G9N) Carmoisine (UNII: DR4641L47F) Amaranth (UNII: 37RBV3X49K) FD&C Blue No. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60691-116-30 227 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 07/15/2013 Labeler - FDN Enterprises,LLC (965743867)