Label: SWIMMERS ITCH GUARD- eucalyptus oil

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated February 17, 2022

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  • ACTIVE INGREDIENT

    EUCALYPTUS OIL 20%

  • PURPOSE

    SKIN PROTECTANT

  • USES

    • PREVENT SWIMMER'S ITCH
    • SAFE FOR CHILDREN
    • LONG LASTING PROTECTION
  • 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. CONSULT PHYSICIAN BEFORE USING IF PREGNANT OR NURSING.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DIRECTIONS (FOR CHILDREN 2 YEARS AND OLDER AND ADULTS):

    Apply sunscreen first, especially spray-on sunscreens which contain alcohol (alcohol removes our product). Before entering the water, apply Swimmer’s Itch Guard to all uncovered skin that will be under water continuously for 5 minutes or longer. Apply liberally and evenly. When coming out of the water, light toweling off is best because it minimizes removal of Swimmer’s Itch Guard. Reapply after 60 minutes of water activity, taking a shower or hot-tub, or repeated hard toweling offs. Wash swimsuits separately in warm water.

  • OTHER INGREDIENTS:

    Fractionated Coconut Oil, Olive Oil, Avocado Oil, High Oleic Safflower Oil, Cinnamon Oil, d-alpha Tocopherol (Vitamin E).

  • PRINCIPAL DISPLAY PANEL

    01b LBL_2022 Revised SwimmersItchGuard_Label_2x8.5_2017_01

  • INGREDIENTS AND APPEARANCE
    SWIMMERS ITCH GUARD 
    eucalyptus oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63264-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63264-102-08237 mL in 1 JAR; Type 0: Not a Combination Product02/18/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/18/2022
    Labeler - RESOLUTIONS LLC (047149101)
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