ZAPNE- salicylic acid 0.5% cloth

Zapne by

Drug Labeling and Warnings

Zapne by is a Otc medication manufactured, distributed, or labeled by Zapne LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Directions:

• Wash skin to remove dirt, oils, and any cosmetics or lotions, then dry thoroughly.
• Open ZAPNE Packet Part 1 - Towelette infused with natrual 0.5% salicylic acid and thoroughly wipe face and neck. Allow to dry and do not rinse.
• Open Zapne Packet part 2-A which contains a green/gray powder of natrual fresh water sponge (spongilla lacustris), natural Aloe Vera, natrual sericin, brown seaweed, organic green tea, organic ginger root, willow bark, and chamomile. Pour its contens into a small mixing bowl.
• Carefully open ZAPNE Packet Part 2-B consisting of hydrogen peroxide 3% and water. Pour its content into a mixing bowl containing the powder.
• Mix thoroughly using your finger (1 minute).
• Apply the ZAPNE mixture as a max over your entire face. Rub vigorously with your fingers, according to your skin sensitivity. Massage in small circular motions. Avoid applying the mask too close to the eyes.
• Allow to drive for about 15 minutes. A tingling sensation may be felt as the mask begins drying and the skin may experience erythema (slight redness),
• Next rinse skin thoroughly by splashing cold water or showering to remove the mask. Do not wipe or scrub face.
• Any skin erythema (slight redness) and tingling sensations gradually fade over 8-24 hours.
• For best results avoid heavy moisturizers for at least 12 hours .
• After skin starts sloughing (shedding) within 3-4 days, scrub your face using an exfoliating scrub, cloth, or loofa to remove any dead skin.
• Avoid direct sunlight for two weeks after using the mask. Use a sunscreen if it is necessary to be in direct sunlight.
• Apply again one week after the first application and contine to apply weekly until the desired results are acheived.

WARNING: Avoid direct contact with eyes. If contact occurs, rinse thoroughly with water or other eye wash fuilds. If the problem persists, see a doctor immediately.

WARNINGS

Warnings: For external use only.

Using other topical acne medications at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one treatment should be used unless directed by a doctor. Avoid direct contact with eyes. If contact occurs, rinse thoroughly with water.

Keepy out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

INACTIVE INGREDIENT

Other Ingredients

Natural Fresh Water Sponge(spongilla

lacustris), organic Aloe Vera, Natural

Sericin, Brown Seaweed, Organic Green

Tea, Organic Ginger Root, Willow Bark

(Salix alba), Organic Chamomile,

Propanediol, Decyl Glucoside, Citric

Acid, Potassium Sorbate, Hydrogen

Peroxide and Water

INDICATIONS & USAGE

Indications: For the treatment of Acne

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center immediately.

PURPOSE

Zapne

Acne Treatment System

• Use Only Once a Week
• Easy 15-minute Mask Treatment
• Fast Acting
• Feel and See it Working
• All NAtrual Ingredients
• Four Complete Weekly Treatments

ACTIVE INGREDIENT

Active ingredients: salicylic acid 0.5% from natural willow bark extract

PRINCIPAL DISPLAY PANEL

• active ingredients:

  salicylic acid 0.5% from

  natural willow bark extract

• Indications: For the treatment of Acne
• Other Ingredients:

  Natural Fresh Water Sponge(spongilla

  lacustris), organic Aloe Vera, Natural

  Sericin, Brown Seaweed, Organic Green

  Tea, Organic Ginger Root, Willow Bark

  (Salix alba), Organic Chamomile,

  Propanediol, Decyl Glucoside, Citric

  Acid, Potassium Sorbate, Hydrogen

  Peroxide and Water

Store above freezing and below 100 F

Warnings: For external use only. Using other topical acne

medications at the same time or immediately following the use

of this product may increase dryness or irritation of the skin. If

this occurs, only one treatment should be used unless directed

by a doctor. avoid direct contact with eyes. If contact occurs,

rinse thoroughly with water.

Keep out of reach of children. If swallowed, get medical help

or contact a Poison Control Center immediately.

Does Not Contain: Benzoyl Peroxide, Parabens,

Phthalates, Sodium Lauryl/Laureth Sulfare, Sodium Methyl

Sulface, Artificial Colors or Fragrances

INGREDIENTS AND APPEARANCE

ZAPNE 
salicylic acid 0.5% cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71024-105
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1300 mg

Inactive Ingredients
Ingredient Name	Strength
SPONGILLA LACUSTRIS (UNII: 6SZ0G98BHM)	1261 mg  in 1300 mg
SILK SERICIN (UNII: 0N1VMU8G9W)	1.08 mg  in 1300 mg
NORI (UNII: 477TV3P5UX)	1.08 mg  in 1300 mg
GREEN TEA LEAF (UNII: W2ZU1RY8B0)	1.08 mg  in 1300 mg
GINGER (UNII: C5529G5JPQ)	1.08 mg  in 1300 mg
WILLOW BARK (UNII: S883J9JDYX)	1.08 mg  in 1300 mg
CHAMOMILE (UNII: FGL3685T2X)	1.08 mg  in 1300 mg
ALOE VERA LEAF (UNII: ZY81Z83H0X)	325 mg  in 1300 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71024-105-11	1 in 1 BOX	10/01/2014
1		4 mg in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	10/01/2014

Labeler - Zapne LLC (080395104)

Registrant - Zapne LLC (080395104)

Establishment
Name	Address	ID/FEI	Business Operations
Zapne LLC		080395104	repack(71024-105) , pack(71024-105) , manufacture(71024-105) , label(71024-105)