ZAPNE (SALICYLIC ACID 0.5%) CLOTH [ZAPNE LLC]

ZAPNE (SALICYLIC ACID 0.5%) CLOTH [ZAPNE LLC]
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NDC 71024-105-11
Set ID 3e147e6b-a0a7-2fb0-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Zapne LLC
Generic Name
Product Class
Product Number
Application Number PART333D
  • 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.

    Dosage And Administration

  • 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.

    Side label

  • 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

    Inactive Ingredients

  • INDICATIONS & USAGE

    Indications: For the treatment of Acne

    Indication

  • KEEP OUT OF REACH OF CHILDREN

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

  • 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

    Purpose

  • ACTIVE INGREDIENT

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

    Active Ingredients

  • PRINCIPAL DISPLAY PANEL

    active ingredients

    salicylic acid 0.5% from

    natural willow bark extract

    IndicationsFor 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

    principal panel

  • INGREDIENTS AND APPEARANCE
    ZAPNE 
    salicylic acid 0.5% cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71024-105
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1300 mg
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71024-105-111 in 1 BOX10/01/2014
    14 mg in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/01/2014
    Labeler - Zapne LLC (080395104)
    Registrant - Zapne LLC (080395104)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zapne LLC080395104repack(71024-105) , pack(71024-105) , manufacture(71024-105) , label(71024-105)

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