Label: NEPTUNE ICE PATCH- lidocaine, menthol, camphor, and dimethicone patch patch
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Contains inactivated NDC Code(s)
NDC Code(s): 72594-1847-8 - Packager: Neptune Products L.L.C.
- 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 April 1, 2021
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- DRUG FACTS
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SPL UNCLASSIFIED SECTION
Methemoglobinemia
Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.
Signs and symptoms of methemoglobinemia may occur immediately or may be delayed some hours after exposure and are characterized by a cyanotic skin discoloration and abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue lidocaine-containing products and any other oxidizing agents. Depending on the severity of the symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. More severe symptoms may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.
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Warnings
For External Use Only
Do Not Use
- On damaged or irritated skin
- With a bandage or heating pad
- If you are allergic to any ingredients in this product
- Other than as directed
- Directions
- Other Information
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Inactive Ingredients
Aloe Barbadensls Leaf Extract, Alcohol, Arnlca Montana Flower Extract, Boswellia Serrata Extracl Butylene Glycol Cellulose Gum Dihydroxyaluminum Aminoecstete, Blycerin, lsopropyl Myristate, Msttwlsulfonylmethene, Partially Neutralized Polyacrylate, Phenoxvethanol, Polvsorbate 80, Porvvinyl Pyrrolidone, Propylene Glycol, Tartaric Acid, Tetrasodium EDTA, Water.
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INGREDIENTS AND APPEARANCE
NEPTUNE ICE PATCH
lidocaine, menthol, camphor, and dimethicone patch patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72594-1847 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 450 mg DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 450 mg LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 600 mg MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 150 mg Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 80 (UNII: 6OZP39ZG8H) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) EDETATE SODIUM (UNII: MP1J8420LU) ALOE VERA LEAF (UNII: ZY81Z83H0X) PHENOXYETHANOL (UNII: HIE492ZZ3T) POVIDONE (UNII: FZ989GH94E) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) TARTARIC ACID (UNII: W4888I119H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72594-1847-8 2 in 1 BOX 04/12/2019 04/12/2019 1 5 in 1 POUCH 1 15000 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 04/12/2019 Labeler - Neptune Products L.L.C. (081502369)