Label: OCEAN POTION INSTANT BURN RELIEF ICE- lidocaine gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 March 21, 2014

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  • 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

  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    OCEAN POTION INSTANT BURN RELIEF ICE 
    lidocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62802-172
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOCETETH-20 (UNII: O020065R7Z)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62802-172-65605 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2012
    Labeler - Sun & Skin Care Research, LLC (849772207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun & Skin Care Research, LLC849772207manufacture(62802-172)
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