FDA Label for Ocean Potion Instant Burn Relief Ice

View Indications, Usage & Precautions

Ocean Potion Instant Burn Relief Ice Product Label

The following document was submitted to the FDA by the labeler of this product Sun & Skin Care Research, Llc. 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.

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


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