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.
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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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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 TypeHUMAN OTC DRUGItem Code (Source)NDC:43074-114
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
zinc acetate (UNII: FM5526K07A) (zinc - UNII:J41CSQ7QDS) zinc0.001 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43074-114-181 in 1 PACKAGE, COMBINATION
1NDC:43074-114-163 mL in 1 VIAL, PLASTIC
2NDC:43074-114-170.003 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/12/2010
Labeler - Phillips Company (612368238)
Establishment
NameAddressID/FEIBusiness Operations
Phillips Company612368238manufacture

Revised: 11/2010
Document Id: 94aab24d-fca0-490a-9eac-822490ac8a54
Set id: 57a5d86e-5fa5-4bc6-9fe9-ec7d617fadfb
Version: 1
Effective Time: 20101112
 
Phillips Company