ZINCON MEDICATED DANDRUFF (PYRITHIONE ZINC) SHAMPOO [NEOTERIC COSMETICS, INC.]

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ZINCON MEDICATED DANDRUFF (PYRITHIONE ZINC) SHAMPOO [NEOTERIC COSMETICS, INC.]
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NDC 62673-016-94, 62673-016-98
Set ID 603b9e94-a7b8-b6e5-e053-2a91aa0a05fd
Category HUMAN OTC DRUG LABEL
Packager Neoteric Cosmetics, Inc.
Generic Name
Product Class
Product Number
Application Number PART358H
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Pyrithione zinc 1%

    (To the right)

  • Purpose

    Anti-dandruff

  • Uses

    • Reduces and helps eliminate scalp itching, flaking and scaling associated with dandruff and seborrheic dermatitis.
  • Warnings:

    • For external use only.

    Ask a doctor before use if you

    have a condition that covers a large area of the body.

    When using this product 

    avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if:

    • Condition worsens
    • Condition does not improve after regular use of this product as directed.

    Keep out of reach of children:

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions:

    • Shake well
    • Wet hair, apply shampoo and work into lather
    • Rinse thoroughly
    • For best results, use at least twice a week or as directed by a doctor
    • Do not use on children under 2 years of age, except as directed by a doctor
  • Inactive Ingredients

    Citric acid, cocamide MEA, deionized water, FD & C Blue No. 1, Fragrance, glycol distearate, magnesium aluminum silicate, methylchloroisothiazolinone, methylisothiazolinone, propylene glycol, sodium chloride, sodium laureth sulfate, sodium lauryl sulfate.

    Questions? 1-800-220-0151

    Manufactured for Neoteric Cosmetics, Inc.

    Denver, CO 80239

    WWW. Neotericcosmetics.com MADE IN USA

  • PRINCIPAL DISPLAY PANEL

    Pyrithione Zinc
    ZINCON
    MEDICATED
    DANDRUFF SHAMPOO

    • Controls dandruff itching & flaking
    • Leaves hair clean & easy to manage
    • Pleasant fragrance

    4 fl.oz. (118ml)

    PRINCIPAL DISPLAY PANEL Pyrithione Zinc ZINCON MEDICATED DANDRUFF SHAMPOO • Controls dandruff itching & flaking • Leaves hair clean & easy to manage • Pleasant fragrance 4 fl.oz. (118ml)

  • PRINCIPAL DISPLAY PANEL

    Pyrithione Zinc
    ZINCON
    MEDICATED
    DANDRUFF SHAMPOO

    • Controls dandruff itching & flaking
    • Leaves hair clean & easy to manage
    • Pleasant fragrance

    8 fl.oz. (236ml)

    PRINCIPAL DISPLAY PANEL Pyrithione Zinc ZINCON MEDICATED DANDRUFF SHAMPOO • Controls dandruff itching & flaking • Leaves hair clean & easy to manage • Pleasant fragrance 8 fl.oz. (236ml)

  • INGREDIENTS AND APPEARANCE
    ZINCON MEDICATED DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62673-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.01 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62673-016-94118 mL in 1 BOTTLE; Type 0: Not a Combination Product12/13/2017
    2NDC:62673-016-98236 mL in 1 BOTTLE; Type 0: Not a Combination Product12/13/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H12/13/2017
    Labeler - Neoteric Cosmetics, Inc. (790615181)
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