Label: REAL SUMMER- sodium chloride patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 December 8, 2014

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  • ACTIVE INGREDIENT

    sodium chloride


  • INACTIVE INGREDIENT

    iron powder, active carbon, resin vermiculite, salty water


  • PURPOSE

    insect bite


  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    When pasting on the mosquito, red ant or other inset bite area, pure mild fever soothes itching, and furthermore soothes festered skin.It can be used for men and women of all ages without adverse effects.Pucca is a character loved by people all around the world, which gives cute and refined image to both infants and adults.

  • WARNINGS

    Be careful for children not to put it to the mouse. Stop using if there is any problem in the use of the product.Keep it in a cool area without direct light.Store it with sealing after the use. Be careful that if attachment and detachment are repeated, its adhesiveness may decrease.

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    REAL SUMMER  
    sodium chloride patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69449-1001
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE0.03 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    IRON (UNII: E1UOL152H7)  
    CARBON DIOXIDE (UNII: 142M471B3J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69449-1001-112 g in 1 PATCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34912/08/2014
    Labeler - Kayone (689312385)
    Registrant - Kayone (689312385)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kayone 689312385manufacture(69449-1001)
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