Label: SHINGLES PAIN RELIEF CREAM- roycederm shingles pain relief cream cream

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated February 24, 2023

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  • Active Ingredient(s)

    Artemisia extract [fhfi] 3%

  • Purpose

    for shingles skin care

  • Use

    For the treatment of symptomsof shingles, hives, and rashes.

  • Warnings

    FOR EXTERNAL USE ONLY

  • Do not use

    it on pregnant womenand children under 12 years ofage unless directed by a doctor

  • WHEN USING

    avoid contact with eyeslf contact occurs, rinse the eyesthoroughly with water.

  • STOP USE

    condition worsens or does notimprove after regular use asdirected

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, getmedical help or contact aPoison Control Center(1-800-222-1222) right away.

  • Directions

    Apply a small amount to theproblem areas with circularmotions for 3 minutes till theskin absorbs the cream.
    Apply it 2-3 times a day for thebest result.

  • Other information

    Store at room temperature andout of direct sunlight

  • Inactive ingredients

    Water, Sophora Flavescens Root,Cnidium Monnieri Fruit, KochiaScoparia Pollen, Dictamnus Dasyca-rpus Root, Smilax Glabra Whole

  • ASK DOCTOR

    if you are allergic to ingredientsin this product.

  • QUESTIONS

    Visit www.roycederm.com

  • Package Label - Principal Display Panel

    81799-009-01

    81799-009-01

  • INGREDIENTS AND APPEARANCE
    SHINGLES PAIN RELIEF CREAM 
    roycederm shingles pain relief cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81799-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WORMWOOD (UNII: F84709P2XV) (WORMWOOD - UNII:F84709P2XV) WORMWOOD3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DICTAMNUS DASYCARPUS ROOT (UNII: 6153LEN214)  
    WATER (UNII: 059QF0KO0R)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    SMILAX GLABRA WHOLE (UNII: H51N91QNEB)  
    CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS)  
    BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81799-009-0160 g in 1 BOTTLE; Type 0: Not a Combination Product02/15/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/15/2023
    Labeler - Ehy Holdings LLC (117322715)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ehy Holdings LLC117322715manufacture(81799-009)
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