Label: WALGREENS DAILY REPAIR PSORIASIS MOISTURIZER- salicylic acid lotion

  • 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 7, 2020

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  • Active Ingredient

    Salicylic Acid 3.0%

  • Purpose

    Psoriasis Treatment

  • INDICATIONS & USAGE

    Uses Relieves and helps prevent recurrence of skin

    • itching
    • irritation
    • redness
    • flaking
    • scaling associates with psoriasis.
  • Warnings

    For external use only

  • ASK DOCTOR

    Ask a doctor before use if you have

    • psoriasis that covers a large area of the body.
  • WHEN USING

    When using this product

    • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens or does not improve after regular use of this product as directed.
  • 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

    • Apply to affected areas one to four times daily or as directed by a doctor.
  • Other information

    • may stain some fabrics
  • Inactive Ingredients

    water, cocamidopropyl dimethylamine, butyrospermum parkii (shea) butter, glycerin, caprylic/capric triglyceride, theobroma cacao (cocoa) seed butter, cetearyl alcohol, cocos nucifera (coconut) oil, glyceryl stearate, PEG-100 stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, sorbitol, isohexadecane, prunus amygdalus dulcis (sweet almond) oil, carthamus tinctorius (safflower) seed oil, aloe barbadensis leaf juice, olea europaea (olive) fruit oil, phenoxyethanol, caprylyl glycol, hexylene glycol, polysorbate 60, polysorbate 80, tocopherol, bisabolol, citric acid, disodium EDTA.

  • QUESTIONS

    Questions or comments? 1-800-925-4733

  • PRINCIPAL DISPLAY PANEL

    WALGREENS DAILY REPAIR PSORIASIS MOISTURIZER

    4 FL OZ. (118mL)

    NDC 0363-0920-04

    W21209

  • INGREDIENTS AND APPEARANCE
    WALGREENS DAILY REPAIR PSORIASIS MOISTURIZER 
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0920
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0920-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358B02/14/2020
    Labeler - WALGREEN COMPANY (008965063)
    Registrant - FRUIT OF THE EARTH, INC. (079559467)
    Establishment
    NameAddressID/FEIBusiness Operations
    FRUIT OF THE EARTH, INC.008193513manufacture(0363-0920)
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