Label: NEPTUNE ICE PATCH- lidocaine, menthol, camphor, and dimethicone patch patch

  • Category: HUMAN OTC DRUG LABEL

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

  • 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.

  • Active Ingredient

    Lidocaine 4%

  • Purpose

    Topical Anesthetic

  • Active Ingredient

    Menthol 1%

  • Purpose

    Topical Analgesic

  • Active Ingredient

    Camphor 3%

  • Purpose

    Topical Analgesic

  • Active Ingredient

    Dimethicone 3%

  • Purpose

    Skin Conditioner

  • Uses:

    For the temporary relief of joint pain and muscle pain associated with:

    • Arthritis
    • Backache
    • Cramps
    • Discomfort
    • 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 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.

    Questions or Comments?

    Info@neptuneice.cool

  • Principal Display Panel

    neptunepatchbox

  • INGREDIENTS AND APPEARANCE
    NEPTUNE ICE PATCH 
    lidocaine, menthol, camphor, and dimethicone patch patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72594-1847
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)450 mg
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE450 mg
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE600 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL150 mg
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72594-1847-82 in 1 BOX04/12/201904/12/2019
    15 in 1 POUCH
    115000 in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/12/2019
    Labeler - Neptune Products L.L.C. (081502369)