Label: SEBORRHEIC DERMATITIS AND PSORIASIS- roycederm seborrheic dermatitis and psoriasis shampoo shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 12, 2023

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  • Active Ingredient(s)

    ARTEMISIA EXTRACT 【FHFI】3%

  • Purpose

    Seborrheic

  • Use

    Relieves and helps preventrecurrence of scalp: itching, flakingscaling, redness, and irritationassociated with psoriasis andseborrheic dermatitis.

  • Warnings

    For external use only

  • Do not use

    Do not use morethan 3 times daily. Children under12 years: ask a doctor

  • WHEN USING

    When using this productavoid contact with eyes.

  • STOP USE

    condition worsens or does notimprove after regular use asdirected

  • KEEP OUT OF REACH OF CHILDREN

    lf swallowed, get medical help orcontact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    Adult and children over 12 vears or old. Wash handsbefore and after applying the cream. Apply to affected area at the firstsign of blisters, sores, or tingling sensation. Rub in gently andthoroughly. Do not use more than 3 times daily. Children under 12years: ask a doctor

  • Other information

    Stor at room temperature and out of directsunlight.

  • Inactive ingredients

    Purified water, Artemisia extractsSophora Flavescens, Cnidium Monnieri (L) Cuss., Kochiascoparia, Dictamni Cortex, Smilax Glabra Roxb, SolidagoDecurrens, Phellodendron amurense Ruprecht., GleditsiaSinensis

  • ASK DOCTOR

    than 3 times daily. Children under12 years: ask a doctor

  • QUESTIONS

    Visit www.roycederm.com

  • Package Label - Principal Display Panel

    81799-007-1

    1

    81799-006-1 1

    81799-007-1

    2

    81799-006-1 2

    81799-007-1

    3

    81799-006-1 3

  • INGREDIENTS AND APPEARANCE
    SEBORRHEIC DERMATITIS AND PSORIASIS 
    roycederm seborrheic dermatitis and psoriasis shampoo shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81799-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WORMWOOD (UNII: F84709P2XV) (WORMWOOD - UNII:F84709P2XV) WORMWOOD3 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DICTAMNUS DASYCARPUS ROOT (UNII: 6153LEN214)  
    WATER (UNII: 059QF0KO0R)  
    SMILAX GLABRA WHOLE (UNII: H51N91QNEB)  
    CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS)  
    BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81799-007-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product01/11/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/11/2023
    Labeler - Ehy Holdings LLC (117322715)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ehy Holdings LLC117322715manufacture(81799-007)
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