SALICYLIC ACID SHAMPOO [ORANGE LAB]

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SALICYLIC ACID SHAMPOO [ORANGE LAB]
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NDC 71331-101-08, 71331-101-32
Set ID 4a64dc7e-543b-51c7-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Orange Lab
Generic Name
Product Class
Product Number
Application Number
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  • Active Ingredient

    Salicylic Acid 2 %

  • Warnings

    Warning section

  • Purpose

    purpose

  • PREGNANCY OR BREAST-FEEDING

    Pregnancy section

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • Inactive Ingredients

    Inactive ingredients

  • Directions

    Directions

  • Shampoo description

    Enfanti Antidandruff Shampoo

  • Directions

    1

  • OTC Active Ingredient

    Active ingredients

  • INDICATIONS & USAGE

    USE:

  • Principal Display Panel

    Enfanti front

  • INGREDIENTS AND APPEARANCE
    ANTI DANDRUFF 
    salicylic acid shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71331-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)  
    MENTHOL (UNII: L7T10EIP3A)  
    C12-16 PARETH-9 (UNII: 9DJ758090Y)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    TRIDECETH-12 (UNII: YFY3KG5Y7O)  
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    WATER (UNII: 059QF0KO0R)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PPG-5-CETETH-20 (UNII: 4AAN25P8P4)  
    SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    URTICA DIOICA LEAF (UNII: X6M0DRN46Q)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
    PAULLINIA CUPANA SEED (UNII: C21GE7524R)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    C11-15 PARETH-7 (UNII: 261HPE0IS3)  
    Product Characteristics
    Colorwhite (Pearly White/Yellowish color) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71331-106-081 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2020
    2NDC:71331-106-321 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/01/2020
    Labeler - Orange Lab (004862271)
    Registrant - Orange Lab (004862271)
    Establishment
    NameAddressID/FEIBusiness Operations
    Orange Lab004862271manufacture(71331-106)
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