Label: INSTANT COOL SKIN INSTANT RELIEF. SUDDEN RESULTS- lidocaine 0.5% lotion

  • 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 June 15, 2015

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  • Active Ingredients

    Lidocaine 0.5%

  • Uses

    External Analgesic

  • Indications

    For temporary relief of pain associated with sunburn and minor skin burns.

  • Warnings

    For external use only, avoid contact with eyes. Do not use in large quantities, particularly over raw surfaces or blistered surfaces

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • STOP USE

    Stop use and ask a doctor if:

    • condition worsens
    • symptoms persist for more than 7 days
    • condition clears up and occurs again within a few days
  • Directions

    • Adults and children 2 years and older: apply to affected area. Do not use more than 3-4x daily. Repeat daily until healed.
    • Children under 2 years of age: consult a doctor
  • Inactive Ingredients

    Water, Ethanol, Propylene Glycol, Lactic Acid

  • Package Display

    label back

  • INGREDIENTS AND APPEARANCE
    INSTANT COOL SKIN  INSTANT RELIEF. SUDDEN RESULTS
    lidocaine 0.5% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66428-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66428-007-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/15/2015
    Labeler - Therapon Skin Health, LP (792518995)
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