Label: PURESKIN ANTI DANDRUFF SHAMPOO.- pureskin anti dandruff shampoo shampoo

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 11, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active Ingredient

    Ketoconazole 0.5%

  • Purpose

    Anti Dandruff

  • Use

    controls flaking, scaling and itching associated with dandruff

  • Warnings

    For external use only.

  • Do not use

    on damaged or inflamed scalp.
    if you are pregnant or breat-feeding.
    in children less than 12 years old.

  • When Using

    avoid contact with eyes
    if product gets into eyes, rinse thoroughly with water

  • Stop Use

    irritation or rash occurs
    condition worsens or does not improve in 2-4 weeks

  • Ask Doctor

    • irritation or rash occurs
    • condition worsens or does not improve in 2-4 weeks

  • Keep Out Of Reach Of Children

    If swallowed, get medical help ot contact a Poison Control Center (1-800-222-1222)right away.

  • Directions

    wet hair thoroughly
    apply shampoo, gently lather and massage for 2 minutes, and then rinse thoroughly.
    use 2-3 times per week for up to 8 weeks or as directed by a doctor.

  • Other information

    store at 15-25 ℃

  • Inactive ingredients

    Aqua
    Glycerin
    Sodium Cocoyl Isethionate
    Propylene Glycol
    Aloe Vera
    Citric Acid
    Rosemary
    Tea Tree Oil
    Witch Hazel
    Chinese Mugwort Leaf
    Licorice
    Ethylhexylglycerin
    Purslane
    Sodium Chloride
    Serine
    Arginine
    Coconut Oi

  • Questions

    info@pureskinsupport.com
    www.pureskinsupport.com

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    PURESKIN ANTI DANDRUFF SHAMPOO. 
    pureskin anti dandruff shampoo shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83565-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WITCH HAZEL (UNII: 101I4J0U34)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PURSLANE (UNII: M6S840WXG5)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    ROSEMARY (UNII: IJ67X351P9)  
    ARTEMISIA ARGYI LEAF (UNII: 2JYC99Q0WZ)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    LICORICE (UNII: 61ZBX54883)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SERINE (UNII: 452VLY9402)  
    ARGININE (UNII: 94ZLA3W45F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83565-009-01300 mL in 1 BOTTLE; Type 0: Not a Combination Product06/11/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03206/11/2024
    Labeler - Stellans Inc. (111157321)
    Establishment
    NameAddressID/FEIBusiness Operations
    Stellans Inc.111157321label(83565-009) , manufacture(83565-009)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!