Label: ADVANCED JELLYFISH STING KIT - zinc acetate powder, for suspension

  • NDC Code(s): 43074-114-16, 43074-114-17, 43074-114-18
  • Packager: Phillips Company
  • 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 November 12, 2010

If you are a consumer or patient please visit this version.

  • DRUG FACTS

    Uses 
    Temporarily protects injured or exposed skin or mucous membrane surfaces from harmful or annoying stimuli, and may help provide relief to such surfaces.  Contains surfactants to break down oily toxins.
    ____________________________________________________________________

    Warnings
    n For external use only; do not swallow.    n Keep away from children.
    n Do not use in the eyes or apply over large areas of the body.
    n Do not use if allergic to any ingredient listed on this label.
    ____________________________________________________________________

    Directions
    Step 1:  Wet the skin with water and apply powder to the affected area.  Step 2: Use water to wet the special cloth and use it to scrub the affected area to remove jellyfish barbs and to mix the protectant with any remaining toxins.  Step 3:  Repeat Steps 1 and 2 a minimum of three times or until stinging and pain stops.  Step 4: Seek immediate medical attention.
    ____________________________________________________________________

    Other information   
    Store at 40 to 120 degrees F.   Net contents of kit:  One special scrub cloth and one powder vial.  Net contents of powder vial:  3 mL.  This product contains no alcohol; no animal products; no biological products.
    ____________________________________________________________________

    Inactive ingredients  
    Water, calcium carbonate, sodium hypochlorite, sodium carbonate, sodium dodecylbenzene sulfonate, ascorbic acid, magnesium stearate, sorbic acid, stearic acid, diproplyene glycol, dimethyl sulfoxide, color.
    ____________________________________________________________________

    Questions and Side effects
    Report any side effects to Phillips Company, 311 Chickasaw St, Millerton, OK USA 74750
    Email:  phillips@123phillips.com  
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  • ACTIVE INGREDIENTS

    Active Ingredients                            Purpose
    Zinc acetate (.1% by volume)           Skin Protectant

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  • ASK DOCTOR

    Directions
    Step 1:  Wet the skin with water and apply powder to the affected area.  Step 2: Use water to wet the special cloth and use it to scrub the affected area to remove jellyfish barbs and to mix the protectant with any remaining toxins.  Step 3:  Repeat Steps 1 and 2 a minimum of three times or until stinging and pain stops.  Step 4: Seek immediate medical attention.

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  • DO NOT USE

    Warnings
    n For external use only; do not swallow.    n Keep away from children.
    n Do not use in the eyes or apply over large areas of the body.
    n Do not use if allergic to any ingredient listed on this label.

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  • CHILDREN

    n Keep away from children.
    n Do not use in the eyes or apply over large areas of the body.
    n Do not use if allergic to any ingredient listed on this label.

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  • PURPOSE


    Active Ingredients                            Purpose
    Zinc acetate (.1% by volume)           Skin Protectant

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  • WHEN USING

    Directions
    Step 1:  Wet the skin with water and apply powder to the affected area.  Step 2: Use water to wet the special cloth and use it to scrub the affected area to remove jellyfish barbs and to mix the protectant with any remaining toxins.  Step 3:  Repeat Steps 1 and 2 a minimum of three times or until stinging and pain stops.  Step 4: Seek immediate medical attention.


    Store at 40 to 120 degrees F.

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  • WARNINGS

    Warnings
    n For external use only; do not swallow.    n Keep away from children.
    n Do not use in the eyes or apply over large areas of the body.
    n Do not use if allergic to any ingredient listed on this label.
    Close
  • DOSAGE & ADMINISTRATION


    Directions
    Step 1:  Wet the skin with water and apply powder to the affected area.  Step 2: Use water to wet the special cloth and use it to scrub the affected area to remove jellyfish barbs and to mix the protectant with any remaining toxins.  Step 3:  Repeat Steps 1 and 2 a minimum of three times or until stinging and pain stops.  Step 4: Seek immediate medical attention.


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  • USE

    Temporarily protects injured or exposed skin or mucous membrane surfaces from harmful or annoying stimuli, and may help provide relief to such surfaces.  Contains surfactants to break down oily toxins.

    Close
  • INACTIVE INGREDIENTS

    Inactive ingredients
    Water, calcium carbonate, sodium hypochlorite, sodium carbonate, sodium dodecylbenzene sulfonate, ascorbic acid, magnesium stearate, sorbic acid, stearic acid, diproplyene glycol, dimethyl sulfoxide, color.

    Close
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  • INGREDIENTS AND APPEARANCE
    ADVANCED JELLYFISH STING KIT 
    zinc acetate powder, for suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:43074-114
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    zinc acetate (UNII: FM5526K07A) (zinc - UNII:J41CSQ7QDS) zinc 0.001 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    dimethyl sulfoxide (UNII: YOW8V9698H)  
    ascorbic acid (UNII: PQ6CK8PD0R)  
    dipropylene glycol (UNII: E107L85C40)  
    water (UNII: 059QF0KO0R)  
    sorbic acid (UNII: X045WJ989B)  
    magnesium stearate (UNII: 70097M6I30)  
    stearic acid (UNII: 4ELV7Z65AP)  
    sodium dodecylbenzenesulfonate (UNII: 554127163Y)  
    calcium carbonate (UNII: H0G9379FGK)  
    sodium carbonate (UNII: 45P3261C7T)  
    sodium hypochlorite (UNII: DY38VHM5OD)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43074-114-18 1 in 1 PACKAGE, COMBINATION
    1 NDC:43074-114-16 3 mL in 1 VIAL, PLASTIC
    2 NDC:43074-114-17 0.003 mL in 1 APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 11/12/2010
    Labeler - Phillips Company (612368238)
    Establishment
    Name Address ID/FEI Business Operations
    Phillips Company 612368238 manufacture
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