Label: MAXXAM DERMACARE PRE-SHAMPOO SCALP TREATMENT- pyrithione zinc shampoo 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 August 19, 2020

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  • ACTIVE INGREDIENT

    Pyrithione Zinc 1.8%

  • INACTIVE INGREDIENT

    Water (Aqua), Cocamidopropyl Hydroxysultaine, Disodium Laureth Sulfosuccinate, Sodium Lauroyl Glutamate, Sodium Methyl Cocoyl Taurate, Zinc Pyrithione, Cocamide MIPA, Glycol Distearate , Decyl Glucoside , Glycerin, Silk Amino Acids, Acrylates Copolymer , Aloe Barbadensis Leaf Extract, Hydroxypropyltrimonium Hydrolyzed Wheat Protein, Chamomilla Recutita (Matricaria) Flower Extract, PEG-150 Pentaerythrityl Tetrastearate, Guar Hydroxypropyltrimonium Chloride, Divinyldimethicone/ Dimethicone Copolymer, Polyquatemium-10, Pro+N2pylene Glycol, Cocodimonium Hydroxypropyl Hydrolyzed Hair Keratin, Phenoxyethanol, Fragrance (Partum), Allantoin, Tetrasodium EDTA, Ctlric Acid, PEG-7 Glyceryl Cocoate, Amodimethicone, Panthenol, Cetrimonium Chloride, Camellia Sinensis Seed Oil, Methylchloroisothiazolinone, Methylisothiazolinone​

  • DOSAGE & ADMINISTRATION

    Use: Anti-dandruff

    Directions: Use once or twice a week on your scalp, beneath your head of hair only. Squeeze a 1/8 oz. of shampoo into your palm (size of half dollar). Massage into scalp. Leave on scalp for 1-2 minutes then rinse thoroughly. Maxxam DermaCare is for the scalp only; it is not intended to cleanse your head of hair. After treatment, use your regular Maxxam Shampoo and Conditioner to cleanse and hydrate your head of hair.

  • INDICATIONS & USAGE

    Use: Anti-dandruff

    Directions: Use once or twice a week on your scalp, beneath your head of hair only. Squeeze a 1/8 oz. of shampoo into your palm (size of half dollar). Massage into scalp. Leave on scalp for 1-2 minutes then rinse thoroughly. Maxxam DermaCare is for the scalp only; it is not intended to cleanse your head of hair. After treatment, use your regular Maxxam Shampoo and Conditioner to cleanse and hydrate your head of hair.

  • WARNINGS

    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 direct.
  • KEEP OUT OF REACH OF CHILDREN

    KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

  • PURPOSE

    Anti-dandruff

  • PRINCIPAL DISPLAY PANEL

    MAXXAM Shampoo PDP

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    MAXXAM DERMACARE PRE-SHAMPOO SCALP TREATMENT 
    pyrithione zinc shampoo shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71203-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1.8 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CHAMOMILE (UNII: FGL3685T2X)  
    PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    AMINO ACIDS, SILK (UNII: V0L00EX1IA)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    AMINO ACIDS, HAIR KERATIN (UNII: G46579QK1M)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71203-006-08240 mL in 1 BOTTLE; Type 0: Not a Combination Product01/25/201801/31/2022
    2NDC:71203-006-10300 mL in 1 BOTTLE; Type 0: Not a Combination Product01/19/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/19/2018
    Labeler - EI GLOBAL GROUP LLC (809220911)
    Registrant - EI GLOBAL GROUP LLC (809220911)