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Name:Advanced Jellyfish Sting Kit
Manufacturer:Phillips Company
Category:Over-the-counter (OTC) Marketed Drugs


DRUG FACTS

ADVANCED JELLYFISH STING KIT  - zinc acetate powder, for suspension 
Phillips Company

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.

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DRUG FACTS

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

ACTIVE INGREDIENTS

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

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.

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.

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.

PURPOSE


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


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.

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.

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.


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.

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.

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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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
zinc acetate (zinc) zinc 0.001 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
dimethyl sulfoxide  
ascorbic acid  
dipropylene glycol  
water  
sorbic acid  
magnesium stearate  
stearic acid  
sodium dodecylbenzenesulfonate  
calcium carbonate  
sodium carbonate  
sodium hypochlorite  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43074-114-18 1 VIAL, PLASTIC ( PACKAGE) in 1 PACKAGE, COMBINATION contains a VIAL, PLASTIC (43074-114-16)
1 NDC:43074-114-16 3 mL in 1 VIAL, PLASTIC This package is contained within the PACKAGE, COMBINATION (43074-114-18)
2 NDC:43074-114-17 0.003 mL in 1 APPLICATOR None

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 Operations
Phillips Company 612368238 manufacture

Revised: 11/2010 Phillips Company



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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