Label: NEPTUNE ICE- lidocaine, menthol, camphor, and dimethicone gel gel
- NDC Code(s): 72594-1846-8
- Packager: Neptune Products L.L.C.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 14, 2023
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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
- DRUG FACTS
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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
- Inactive Ingredients
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INGREDIENTS AND APPEARANCE
NEPTUNE ICE
lidocaine, menthol, camphor, and dimethicone gel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72594-1846 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 0.0291 g in 1 mL DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 0.0291 g in 1 mL LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 0.0388 g in 1 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.0097 g in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) POLYSORBATE 20 (UNII: 7T1F30V5YH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K) WATER (UNII: 059QF0KO0R) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) ALCOHOL (UNII: 3K9958V90M) TROLAMINE (UNII: 9O3K93S3TK) SORBITOL (UNII: 506T60A25R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72594-1846-8 89 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 10/10/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 10/10/2018 Labeler - Neptune Products L.L.C. (081502369)