Label: DERMAZOR PSORIASIS AND SEBORRHEIC DERMATITIS- salicylic acid, zinc oxide 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 January 16, 2020

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  • Active Ingredients

    Salicylic acid 3%

  • Purpose

    Psoriasis and Seborrheic Dermatitis

  • Uses

    Relieves and helps prevent symptomatic recurrence of the skin:


    • Itching
    • Irritation
    • Redness
    • Flaking
    • Scaling
    • Dryness
  • Warnings

    For external use only.

    Keep out of reach of children

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

    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 as directed.

    Side effects

    DermaZor has no side effects. If you are allergic to any of the ingredients in the cream, do not use.

  • Directions

    Apply to the affected areas two to four times daily or as directed by a medical doctor.

  • Other Information

    Keep carton for full drug facts.

  • Inactive Ingredients

    anthemis nobilis flower oil, beeswax, bisabolol, borago officianalis seed oil, calamine, calendula officinalis flower oil, cannabis sativa seed oil, lanolin, lavandula angustifolia oil, linum usitatissimum seed oil, nigella sativa seed oil, oenothera biennis (evening primrose) oil, petrolatum, phenoxyetahnol,
    polysorbate 80, prunus amygdalus dulcis (sweet almond) oil, retinyl palmitate (vitamin A), silybum marinum seed oil, sorbitan tristearate, tocopheryl
    acetate (vitamin E), vitis vinifera (grape) seed oil, water, zea mays (corn) starch, zinc oxide.

  • Questions or Comments:

    support@DermaZor.com

    Website: www.DermaZor.com

  • SPL UNCLASSIFIED SECTION

    Distributed by: DISTR.MED.LLC USA
    Stirling RD Davie, Florida 33024 | T 754.816.5411


    Made in Israel | www.DermaZor.com
    FDA OTC Listed | NDC #63302-202-02

  • Principal Display Panel

    NDC: 63302-202-02

    DermaZor Psoriasis

    MEDICATED SKIN TREATMENT

    Psoriasis and Seborrheic Dermatitis Cream

    Hypoallergenic No Side Effects

    Relieves and helps prevent Symptomatic recurrences:

    • Itching
    • Irritation
    • Redness
    • Flaking
    • Scaling
    • Dryness

    A Patented Unique Formula

    3% Salicylic Acid, Zinc and Cannabis Oil Complex

    Non-Steroidal, Non-Coal Tar

    FL OZ | 100 ml 3.5

    Label

  • INGREDIENTS AND APPEARANCE
    DERMAZOR  PSORIASIS AND SEBORRHEIC DERMATITIS
    salicylic acid, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63302-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    POLYSORBATE 65 (UNII: 14BGY2Y3MJ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SILYBUM MARIANUM SEED OIL (UNII: NYY23HEN06)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    VITAMIN A (UNII: 81G40H8B0T)  
    VITAMIN D (UNII: 9VU1KI44GP)  
    BORAGE SEED OIL (UNII: F8XAG1755S)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63302-202-01100 g in 1 TUBE; Type 0: Not a Combination Product05/05/2014
    2NDC:63302-202-02100 g in 1 TUBE; Type 0: Not a Combination Product08/17/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H05/05/2014
    Labeler - PRESTIGIO LTD (514838031)
    Registrant - PRESTIGIO LTD (514838031)
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