Neptune Ice

Manufacturer
A-S Medication Solutions
Effective date
2021-06-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:40:49

Label at a glance#

ProductNeptune Ice
Active ingredientCAMPHOR (NATURAL), DIMETHICONE, LIDOCAINE, MENTHOL
Label structure16 sections

Indications and uses

For the temporary relief of joint pain and muscle pain associated with: Arthritis Backache Discomfort Cramps Neckache Soreness Sprains Strains

Dosage and administration

Ad ults 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

Label contents#

Full prescribing information#

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

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 1%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Camphor 3%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 3%

Purpose

OTC - PURPOSE SECTION

Skin Conditioner

Uses:

INDICATIONS & USAGE SECTION

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

  • Arthritis
  • Backache
  • Discomfort
  • Cramps
  • Neckache
  • Soreness
  • Sprains
  • Strains

Warnings

WARNINGS SECTION

For External Use Only

Flammable

SPL UNCLASSIFIED SECTION

Keep away from excessive heat or open flame

Do Not Use

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

Avoid contact with the eyes

Stop Use and Ask a Doctor If

OTC - ASK DOCTOR SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If ingested, seek medical help or contact a Poison Control Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

  • Store in a cool, dry place with lid tightly closed

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

(877) 985-8377

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-4640

NDC: 50090-4640-0 89 mL in a TUBE, WITH APPLICATOR

Lidocaine, Menthol, Camphor, and Dimethicone Gel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2186001camphor 3 % / dimethicone 3 % / lidocaine 4 % / menthol 1 % Topical GelPSN3
2186001camphor 0.03 MG/MG / dimethicone 0.03 MG/MG / lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Topical GelSCD3
2186001camphor 3 % / dimethicone 3 % / lidocaine 4 % / menthol 1 % Topical GelSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4640-02023-01-30C16284748780-1f386c649-e8e9-0266-e053-dadaa90a7c1aNeptune Ice

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4640-0Neptune Ice89 mL in 1 TUBE, WITH APPLICATORGEL893

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4640NEPTUNE ICE (LIDOCAINE, MENTHOL, CAMPHOR, AND DIMETHICONE) GEL [A-S MEDICATION SOLUTIONS]3Legacy NDC, 1 package rows20210615_e7877b23-17d6-4484-86a0-4123efacf2d2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72594-1846-8GM - Gram72594-18467ee52ed6-61c3-409d-9887-d0afcf176fcc12019-08-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-464050090-4640-0
72594-1846

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
accec53c-ad9c-4a26-a776-1e3065f4a867e7877b23-17d6-4484-86a0-4123efacf2d22021-06-14WarningsExact identifier
spl id: accec53c-ad9c-4a26-a776-1e3065f4a867
spl set id: e7877b23-17d6-4484-86a0-4123efacf2d2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.