Label: AS I AM DRY AND ITCHY SCALP CARE CO WASH- pyrithione zinc emulsion

  • NDC Code(s): 72474-103-01
  • 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 July 30, 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.
    • Rub a liberal amount of product between palms and distribute throughout hair and scalp. Work product through hair & massage scalp with fingertips as you would a conventional shampoo. For easy detangling carefully comb through hair with a wide-tooth comb before rinsing co-wash from hair.
    • Rinse and repeat if needed. Follow with conditioning.
  • Inactive Ingredient

    Aqua/Water/Eau, Betaine, Cetearyl Alcohol, Aloe Barbadensis Leaf

    Juice, Cetrimonium Chloride, Glycerin, Quaternium-18, Polysorbate 60,

    Olea Europaea (Olive) Fruit Oil, Melaleuca Alternifolia (Tea Tree) Leaf

    Oil, Phytosterols, Mentha Piperita (Peppermint) Oil, Stearamidopropyl

    Dimethylamine,Caprylic Acid, Quaternium-80, Propanediol, Cocos

    Nucifera (Coconut) Oil, Fragrance/Parfum, Phenoxyethanol, Potassium

    Chloride, Linum Usitatissimum (Linseed) Seed Extract, Ceramide NG,

    Sodium Lauroyl Lactylate, Caprylyl Glycol, Piroctone Olamine, Menthol,

    Polyacrylamide, Origanum Vulgare Leaf Extract, Propylene Glycol

    Dicaprylate/Dicaprate, Sodium Cocoyl Isethionate, Sodium Lauroyl

    Glutamate, PEG-3 Distearate, Laureth-9, PEG-8, Ceteareth-25,

    Propylene Glycol, Citric Acid, Polyquaternium-37, PPG-1 Trideceth-6,

    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 Co-Wash

    16 OZ (454g)

    NDC 72474-103-01

    Label

  • INGREDIENTS AND APPEARANCE
    AS I AM  DRY AND ITCHY SCALP CARE CO WASH
    pyrithione zinc emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72474-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    .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)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    MENTHOL (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
    OREGANO (UNII: 0E5AT8T16U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    QUATERNIUM-18 (UNII: O7757NO1VL)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    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)  
    POLIDOCANOL (UNII: 0AWH8BFG9A)  
    STEARDIMONIUM HYDROXYPROPYL PEG-7 DIMETHICONE PHOSPHATE CHLORIDE (UNII: 7PDD38B23D)  
    CERAMIDE NG (UNII: C04977SRJ5)  
    CETEARETH-25 (UNII: 8FA93U5T67)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)  
    PEG-3 DISTEARATE (UNII: 8420ECX438)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72474-103-01454 g in 1 JAR; 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(72474-103)
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