Label: FIRST AID BEAUTY ANTI-DANDRUFF- pyrithione zinc shampoo

  • NDC Code(s): 69423-591-23, 69423-591-30
  • Packager: The Procter & Gamble Manufacturing Company
  • 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 January 31, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Pyrithione zinc 1.00%

  • Purpose

    Anti-dandruff

  • Uses

    helps eliminate and reduces recurrence of the symptoms of dandruff.

  • 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 after regular use of this product as directed.

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

  • Directions

    • Shake before use.
    • Wet hair, massage onto scalp. Leave on for several minutes. Rinse. Repeat if desired
    • Follow with conditioner
    • For best results use at least twice a week or as directed by a doctor
    • For effective control, use every time you shampoo.
  • Inactive Ingredients

    Water, sodium cocoyl isethionate, cocamidopropyl betaine, acrylates copolymer, sodium methyl cocoyl taurate, glycol distearate, sodium chloride, glycerol, sodium cocoyl glycinate, phenoxyethanol, guar hydroxypropyl­trimonium chloride, sorbitan oleate decylglucoside crosspolymer, sodium hydroxide, coconut acid, sodium cocoate, calendula officinalis flower extract, caprylyl glycol, chamomilla recutita (matricaria) flower extract, colloidal oatmeal, decylene glycol, citrus aurentium dulcis (orange) peel extrect, citrus paredisi (grepefruit) fruit extract, lavandula angustifolia (lavender) flower􀀭eaf/stem extract, mangifera indica (mango) fruit extract, pyrus malus (apple) fruit extract, linalool, maltodextrin, cocos nucifera (coconut) oil, DL-panthenol, DL-alpha tocopheryl acetate, chrysanthemum parthenium (feverfew) extract, helianthus annuus (sunflower) seed oil, cocos nucifera (coconut) fruit extract, cucumis melo (melon) fruit extract, mentha piperita (peppermint) leaf extract, prunus armeniaca (apricot) kernel extract, prunus persica (peach) fruit extract, camellia sinensis leaf extract, glycyrrhiza glabra (licorice) root extract, hydrolyzed silk, gardenia jasminoides fruit extract, annafto, citrus aurantium bergamia (bergamot) fruit extract, rubus idaeus (respberry) fruit extract, ascorbyl palmitate, d-alpha tocopherol, ethylhexylglycerin, tetrasodium EDTA

  • Questions (or comments)?

    888-FAB-3063

  • SPL UNCLASSIFIED SECTION

    Dist. by FIRST AID BEAUTY LTD
    Newton, MA 02458

  • PRINCIPAL DISPLAY PANEL - 236.5 mL Bottle Label

    First Aid Beauty®

    FAB

    1% pyrithione zinc dandruff shampoo

    Sulfate-Free

    Safe For Color-Treated Hair

    Safe for Sensitive Skin

    Dermatologist Tested

    No Artificial Fragrance

    236.5 mL (8.0 FL OZ)
    FAB

  • INGREDIENTS AND APPEARANCE
    FIRST AID BEAUTY ANTI-DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-591
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    COCONUT ACID (UNII: 40U37V505D)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ORANGE PEEL (UNII: TI9T76XD44)  
    TANACETUM PARTHENIUM WHOLE (UNII: 6GE7Z0761K)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    COCONUT (UNII: 3RT3536DHY)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PRUNUS ARMENIACA SEED (UNII: 75356789IW)  
    RASPBERRY (UNII: 4N14V5R27W)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    MUSKMELON (UNII: ZV095H5633)  
    ANNATTO (UNII: 6PQP1V1B6O)  
    OATMEAL (UNII: 8PI54V663Y)  
    MANGO (UNII: I629I3NR86)  
    APPLE (UNII: B423VGH5S9)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549)  
    DECYLENE GLYCOL (UNII: S57M60MI88)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    GELATIN HYDROLYZATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)  
    PEACH (UNII: 3OKE88I3QG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-591-3030 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/30/2021
    2NDC:69423-591-23236.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03207/30/2021
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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