ADVANCED JELLYFISH STING KIT- zinc acetate powder, for suspension

Advanced Jellyfish Sting Kit by

Drug Labeling and Warnings

Advanced Jellyfish Sting Kit by is a Otc medication manufactured, distributed, or labeled by Phillips Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

STOP USE

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.

Image of product

Image of product

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