Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 57a5d86e-5fa5-4bc6-9fe9-ec7d617fadfb
Route
TOPICAL
Published
Effective Date 2010-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc (0.001 mg)
Inactive Ingredients
Dimethyl Sulfoxide Ascorbic Acid Dipropylene Glycol Water Sorbic Acid Magnesium Stearate Stearic Acid Sodium Dodecylbenzenesulfonate Calcium Carbonate Sodium Carbonate Sodium Hypochlorite

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-11-12

Description

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:  [email protected]  

Purpose

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


Medication Information

Purpose



Active Ingredients                            Purpose

Zinc acetate (.1% by volume)           Skin Protectant



Description

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:  [email protected]  

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.

Section 50566-9


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.

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.

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.



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:  [email protected]  

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.

Image of Product

Image of product







Active Ingredients

Active Ingredients                            Purpose

Zinc acetate (.1% by volume)           Skin Protectant



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.

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.




Structured Label Content

Use (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.

Section 50566-9 (50566-9)


Purpose (PURPOSE)



Active Ingredients                            Purpose

Zinc acetate (.1% by volume)           Skin Protectant



Children (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.

Warnings (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.

Ask Doctor (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 (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.



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.

____________________________________________________________________



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:  [email protected]  

When Using (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.

Image of Product (Image of product)

Image of product







Active Ingredients (ACTIVE INGREDIENTS)

Active Ingredients                            Purpose

Zinc acetate (.1% by volume)           Skin Protectant



Inactive Ingredients (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.

Dosage & Administration (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.




Advanced Ingredient Data


Raw Label Data

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