ZAPZYT ACNE WASH CLEANSER (SALICYLIC ACID) GEL [FOCUS CONSUMER HEALTHCARE, LLC]

ZAPZYT ACNE WASH CLEANSER (SALICYLIC ACID) GEL [FOCUS CONSUMER HEALTHCARE, LLC]
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NDC 71687-0007-1
Set ID 6078c812-947f-3be0-e053-2a91aa0aafb0
Category HUMAN OTC DRUG LABEL
Packager Focus Consumer Healthcare, LLC
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENT

    Salicylic Acid 2%

  • PURPOSE

    For the treatment of acne

  • INDICATIONS & USAGE

    For external use only.

  • WARNINGS

    For external use only.

    • avoid contact with the eyes. If contact occurs, flush thoroughly with water.
    • 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 medication should be used unless directed by a physician

    Do not use

    • if you are allergic to aspirin or any other pain reliever/fever reducer

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    Ask a doctor before use if

    • you have liver disease
    • the stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic

    Ask a doctor or pharmacist before use

    if you are taking a prescription drug for gout, diabetes or arthritis

    Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • you experience any of the following signs of stomach bleeding:
      • feel faint
      • vomit blood
      • have bloody or black stools
      • have stomach pain that does not get better
    • redness or swelling is present
    • new symptoms occur
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • ringing in the ears or loss of hearing occurs

    If pregnant or breast-feeding,

    ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    • use twice daily
    • add water
    • apply to hands
    • massage gently to the affected area
    • rinse thoroughly
  • INACTIVE INGREDIENT

    Purified water, Disodium EDTA, Chamomile Extract, Aloe Vera Gel, Bioterge AS-40, Cocamidopropyl Betaine, Glucamate DOE-120, Glydant, Sodium Chloride

  • PRINCIPAL DISPLAY PANEL

    acnewashcleanser

  • INGREDIENTS AND APPEARANCE
    ZAPZYT ACNE WASH CLEANSER 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71687-0007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71687-0007-1188.5 g in 1 TUBE; Type 0: Not a Combination Product12/16/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/16/2017
    Labeler - Focus Consumer Healthcare, LLC (080743737)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, LLC001207208manufacture(71687-0007)

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