Ocean Potion Instant Burn Relief Ice
FDA Label NDC 62802-172

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sun & Skin Care Research, Llc for the product Ocean Potion Instant Burn Relief Ice (NDC 62802-172). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, keep out of reach of children, inactive ingredient section, directions, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Lidocaine 0.5%

Purpose

Temporarily Relieves pain due to:

  • sunburn
  • minor burns

Uses

Temporarily Relieves pain and itching due to:

  • sunburn
  • minor burns

Warnings

For external use only.  Do not swallow.  Avoid contact with eyes.  If contacted, flush eyes with water.  Should a rash or irritation develops, discontinue use.  If condition worsens, or if symptoms persist for more than 7 days, consult a physician.  Do not use in large quantities, particularly over raw surfaces or blistered areas.  Keep out of the reach of children.

Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredient Section

Inactive Ingredients: Acrylates / C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, CI 42090, DMDM Hydantoin, Fragrance, Glycerin, Isoceteth-20, Melaleuca Alternifolia (Tea Tree Oil), Menthol, Methylparaben, Phenoxyethanol, Propylene Glycol, Propylparaben, Symphytum Officinale (Comfrey) Extract, Triethanolamine, Water

Directions

Adults and children 2 years of age and older, apply to the affected area not more than 3 to 4 times daily.  Children under 2 years of age, consult a physician.

Storage And Handling


  • protect this product from excessive heat and direct sun
  • for use on skin only

Package Label.Principal Display Panel

Image Of Carton Label (00072)

Image Of Carton Label (00072)

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