Label: NEPTUNE ICE- lidocaine, menthol, camphor, and dimethicone gel
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Contains inactivated NDC Code(s)
NDC Code(s): 50090-4640-0 - Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 72594-1846
- 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 June 14, 2021
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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
- Active Ingredient
- Purpose
- Active Ingredient
- Purpose
- Active Ingredient
- Purpose
- Active Ingredient
- Purpose
- Uses:
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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
- HOW SUPPLIED
- Lidocaine, Menthol, Camphor, and Dimethicone Gel
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INGREDIENTS AND APPEARANCE
NEPTUNE ICE
lidocaine, menthol, camphor, and dimethicone gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-4640(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) INDIAN FRANKINCENSE 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:50090-4640-0 89 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 10/22/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/10/2018 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-4640)
