FDA Label for Neptune Ice
View Indications, Usage & Precautions
Neptune Ice Product Label
The following document was submitted to the FDA by the labeler of this product A-s Medication Solutions. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
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
Active Ingredient
Lidocaine 4%
Menthol 1%
Camphor 3%
Dimethicone 3%
Purpose
Topical Anesthetic
Topical Analgesic
Topical Analgesic
Skin Conditioner
Uses:
For the temporary relief of joint pain and muscle pain associated with:
- Arthritis
- Backache
- Discomfort
- Cramps
- Neckache
- Soreness
- Sprains
- Strains
Warnings
For External Use Only
Flammable
Keep away from excessive heat or open flame
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
When Using This Product
Avoid contact with the eyes
Stop Use And Ask A Doctor If
- Condition worsens
- Excessive skin irritation develops
- Symptoms persist for more than 7 days, or symptoms clear up and occur again within 3 days
If You Are Pregnant Or Breast Feeding
Ask a health professional before use
Keep Out Of Reach Of Children
If ingested, seek medical help or contact a Poison Control Center immediately
Directions
Adults and Children 12 years of Age and Older:
- Clean and dry the affected area
- Apply product directly to your skin, up to 4 times daily
Other Information
- Store in a cool, dry place with lid tightly closed
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Arnica Montana Flower, Boswellia Serrata Extract, Carbomer, Ethylhexylglycerin, FD&C Blue #1, Methylsulfonylmethane, Phenoxyethanol, Polysorbate 20, SD-Alcohol 40B, Sorbitol, Triethanolamine, Water.
Questions Or Comments?
(877) 985-8377
How Supplied
Product: 50090-4640
NDC: 50090-4640-0 89 mL in a TUBE, WITH APPLICATOR
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