OCEAN POTION INSTANT BURN RELIEF ICE (LIDOCAINE) GEL [SUN & SKIN CARE RESEARCH, LLC]

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OCEAN POTION INSTANT BURN RELIEF ICE (LIDOCAINE) GEL [SUN & SKIN CARE RESEARCH, LLC]
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NDC 62802-172-65
Set ID 70392efa-5b3e-4b5b-81bb-3d1b4e7db955
Category HUMAN OTC DRUG LABEL
Packager Sun & Skin Care Research, LLC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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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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