Label: RESTORAL- salicylic acid cream cream

  • 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 June 14, 2018

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  • PRINCIPAL DISPLAY PANEL

    Restoral OTC

    Salicylic Acid, 2%

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

    Uses
    Relieves and helps prevent recurrence of skin itching

    • irritation
    • redness
    • flaking
    • scaling

    due to psoriasis and seborrheic dermatitis

    Directions

    • apply to affected areas one to four times daily or as directed by a doctor
    • massage a liberal amount of the product into skin until thoroughly absorbed

    Directions

    • apply to affected areas one to four times daily or as directed by a doctor
    • massage a liberal amount of the product into skin until thoroughly absorbed

    Inactive ingredients

    water, glyceryl stearate, PEG-100 stearate, glycerin, niacinamide, calendula officinalis flower oil, cannabis sativa seed oil, cetyl alcohol, butyrospermum parkii (shea butter), petrolatum, allantoin, steareth-21, tocopheryl acetate (vitamin E), lavandula angustifolia (lavender) oil, xanthan gum, dipotassium glycyrrhizate, aloe barbadensis leaf juice, triethanolamine, bisabolol, disodium EDTA, maris sal (dead sea mineral water).

  • INGREDIENTS AND APPEARANCE
    RESTORAL 
    salicylic acid cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69435-1805
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID3 g  in 150 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    STEARETH-21 (UNII: 53J3F32P58)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    WATER (UNII: 059QF0KO0R)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    TROLAMINE SALICYLATE (UNII: H8O4040BHD)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    ALLANTOIN (UNII: 344S277G0Z)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69435-1805-1150 mL in 1 CONTAINER; Type 0: Not a Combination Product06/14/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H06/14/2018
    Labeler - Peer Pharma Ltd. (514678390)
    Registrant - Peer Pharma Ltd. (514678390)
    Establishment
    NameAddressID/FEIBusiness Operations
    Peer Pharma Ltd.514678390manufacture(69435-1805)
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