SWIMMERS ITCH GUARD SPF 30 (ZINC OXIDE, EUCALYPTUS OIL) CREAM [RESOLUTIONS LLC]

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SWIMMERS ITCH GUARD SPF 30 (ZINC OXIDE, EUCALYPTUS OIL) CREAM [RESOLUTIONS LLC]
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NDC 63264-101-16
Set ID b922ff00-52de-4d77-82a2-6a1fde9e4f0f
Category HUMAN OTC DRUG LABEL
Packager RESOLUTIONS LLC
Generic Name
Product Class
Product Number
Application Number PART352
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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    ZINC OXIDE 15%

    EUCALYPTUS OIL 20%

  • PURPOSE

    PURPOSE

    SUNSCREEN

    SKIN PROTECTANT

  • INDICATIONS & USAGE

    USES

    • PREVENTS SUNBURN
    • PREVENT ITCHING
  • WARNINGS

    WARNINGS

    TOPICAL CREAM - FOR EXTERNAL USE ONLY - KEEP OUT OF EYES. FLUSH THOROUGHLY AND GENTLY WITH WARM WATER FOR 10-15 MINUTES. STOP USE AND CONSULT PHYSICIAN IF RASH OR IRRITATION DEVELOPS.

  • DO NOT USE

    DO NOT APPLY TO DAMAGED OR BROKEN SKIN. MAY STAIN SOME FABRICS. ALLERGY INFORMATION: CONTAINS COCONUT AND ALMOND OIL.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: APPLY TO AFFECTED AREA NOT MORE THAN 3 TO 4 TIMES DAILY
    • RUB IN THOROUGHLY UNTIL IT IS ABSORBED.
  • INACTIVE INGREDIENT

    NON-MEDICINAL INGREDIENTS:

    COCONUT OIL, HYDROGENATED, PETROLATUM, OZOKERITE WAX, BEES WAX, BLEACHED, SHEA BUTTER, CETYL ALCOHOL, GLYCERYL MONOSTEARATE, D-ALPHA TOCOPHEROL (VITAMIN E), ALMOND OIL, SWEET, SODIUM BENZOATE

  • PRINCIPAL DISPLAY PANEL

    Swimmer's Itch Guard 03 28 2014

  • INGREDIENTS AND APPEARANCE
    SWIMMERS ITCH GUARD  SPF 30
    zinc oxide, eucalyptus oil cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63264-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662) 20 g  in 100 mL
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CERESIN (UNII: Q1LS2UJO3A)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63264-101-16237 mL in 1 JAR; Type 0: Not a Combination Product12/29/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/29/2013
    Labeler - RESOLUTIONS LLC (047149101)
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