Label: AS I AM DRY AND ITCHY SCALP CARE CONDITIONER- pyrithione zinc lotion

  • NDC Code(s): 72474-101-01
  • Packager: Salon Commodities, Inc.
  • 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 August 9, 2021

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  • Active Ingredient

    Zinc Pyrithione 1%

  • Purpose

    Anti-Dandruff, Seborrheic Dermatitis

  • Uses

    For the relief of scalp itching, flaking, and irritation associated with dandruff and seborrheic dermatitis.

  • Warnings

    • For external use only.
  • When Using This Product

    • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
  • Stop use and ask a doctor if

    • Condition worsens or does not improve with regular use.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • For best results, use at least twice a week, or as directed by a doctor.
    • Shake well before use.
    • After shampooing apply by massaging onto wet hair and scalp. Follow with As I Am Dry & Itchy Scalp Care Leave-In Conditioner and As I Am Dry & Itchy Scalp Care Oil Treatment.
  • Inactive Ingredient

    Aqua/Water/Eau, Aloe Barbadensis Leaf Juice, Cocos Nucifera (Coconut) Oil, Cetearyl

    Alcohol, Betaine, Glycerin, Olea Europaea (Olive) Fruit Oil, Behentrimonium Chloride,

    Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mentha Piperita (Peppermint) Oil, Linum

    Usitatissimum (Linseed) Seed Extract, Fragrance/Parfum, Piroctone Olamine, Phytosterols,

    Polyquaternium-37, Quaternium-80, Stearamidopropyl Dimethylamine, Caprylic Acid,

    Polyquaternium-10, Propylene Glycol Dicaprylate/Dicaprate, Phenoxyethanol,

    Polyacrylamide, Caprylyl Glycol, Menthol, Dipropylene Glycol, Propanediol, PPG-1

    Trideceth-6, Origanum Vulgare Leaf Extract, Citric Acid, Potassium Sorbate, Sodium

    Benzoate, Citronellol, Geraniol, Hexyl Cinnamal, Linalool

  • QUESTIONS

    Questions or comments? www.asiamnaturally.com

  • PRINCIPAL DISPLAY PANEL

    As I Am - Dry & Itchy Scalp Care - Olive and Tea Tree Oil Conditioner

    12 FL OZ (355 ml)

    NDC 72474-101-01

    Label

  • INGREDIENTS AND APPEARANCE
    AS I AM  DRY AND ITCHY SCALP CARE CONDITIONER
    pyrithione zinc lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72474-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
    2-(CYCLOHEXYLAMINO)ETHANESULFONIC ACID (UNII: 71X53V3RZ1)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
    OREGANO (UNII: 0E5AT8T16U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GERANIOL (UNII: L837108USY)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    BETAINE (UNII: 3SCV180C9W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    PIROCTONE OLAMINE (UNII: A4V5C6R9FB)  
    STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)  
    CAPRYLIC ACID (UNII: OBL58JN025)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    MENTHOL (UNII: L7T10EIP3A)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72474-101-01355 mL in 1 BOTTLE; Type 0: Not a Combination Product07/26/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H07/26/2018
    Labeler - Salon Commodities, Inc. (046900541)
    Registrant - Avlon Industries Inc (121278626)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avlon Industries Inc121278626manufacture(72474-101)
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