Label: DERMAER PSORIASIS THERAPEUTIC- salicylic acid ointment

  • 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 November 9, 2021

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  • Active Ingredient

    Salicylic Acid....2%

  • Purpose

    Psoriasis treatment

  • Uses

    Relieves and helps prevent scaly plaques

    • itching
    • irritation
    • redness and flaking due to psoriasis
  • Warnings

    For external use only

    When using this product

    avoid contact with eyes. If contact occurs, rinse eyes thoroughly with lukewarm water.

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply to the affected area one to three times a day or as directed by a doctor.

    • Apply on clean and dry skin in circular motion.
    • To avoid running or dripping, lightly squeeze the tube.
  • Other information

    Store between 63°/80°F (17-30C)

    Protect from humidity.

  • Inactive Ingredients

    water, mineral oil, cera alba, grape seed oil, jojoba oil, sweet almond oil, cetyl alcohol, glyceryl stearate, decyl oleate, coconut oil, wheat germ oil, steareth 2, steareth 21, shea butter, phenoxyethanol, triethylene glycol, Xanthan gum, vitamin E, B.H.T, farnesol

  • Principal Display Panel

    NDC 70794-207-14

    DermaER

    Psoriasis Therapeutic ointment

    Relieves and prevents skin irritation, itching, redness and flaking.

    Infused vitamin E

    Does not contain Steroids, Cortisone, Fragrances and Colorings

    1.69 fl.oz (50 ml)

    www.dermaer.com

    NDC 70794-207-16

    DermaER

    Psoriasis Therapeutic ointment

    1

    Relieves and prevents

    • Irritation
    • Itching
    • Redness
    • Scaling

    FDA REGISTERED

    Does not contain Steroids, Cortisone, Fragrances and Colorings

    2 fl.oz (59 ml)

    www.DermaER.com

    NDC 70794-207-17

    DermaER

    Psoriasis Therapeutic ointment

    1

    Relieves and prevents

    • Irritation
    • Itching
    • Redness
    • Scaling

    FDA REGISTERED

    Does not contain Steroids, Cortisone, Fragrances and Colorings

    2.75 fl.oz (81 ml)

    www.DermaER.com

    NDC 70794-207-18

    DermaER

    Psoriasis Therapeutic ointment

    1

    Relieves and prevents

    • Irritation
    • Itching
    • Redness
    • Scaling

    FDA REGISTERED

    Does not contain Steroids, Cortisone, Fragrances and Colorings

    3.5fl.oz (103 ml)

    www.DermaER.com

    pic

  • INGREDIENTS AND APPEARANCE
    DERMAER PSORIASIS THERAPEUTIC  
    salicylic acid ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70794-207
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DECYL OLEATE (UNII: ZGR06DO97T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIETHYLENE GLYCOL (UNII: 3P5SU53360)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    FARNESOL (UNII: EB41QIU6JL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70794-207-1450 g in 1 TUBE; Type 0: Not a Combination Product06/29/2016
    2NDC:70794-207-1659 g in 1 TUBE; Type 0: Not a Combination Product02/22/2017
    3NDC:70794-207-1781 g in 1 TUBE; Type 0: Not a Combination Product02/22/2017
    4NDC:70794-207-18103 g in 1 TUBE; Type 0: Not a Combination Product02/22/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358B06/29/2016
    Labeler - Chen Cohen Industries Inc. (080534875)
    Registrant - Chen Cohen Industries Inc. (080534875)
    Establishment
    NameAddressID/FEIBusiness Operations
    Peer Pharm Ltd.514678390manufacture(70794-207)
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