Label: ZINCON MEDICATED DANDRUFF- pyrithione zinc shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 19, 2020

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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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