Label: DERMOSCRIBE SEBORRHEIC DERMATITIS- sulfur, salicylic acid, hydrocortisone cream

  • Category: HUMAN OTC DRUG LABEL

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 October 3, 2023

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  • ACTIVE INGREDIENTS

    Sulfur 3%, Salicylic Acid 3%, Hydrocortisone 1%

  • PURPOSE

    TREATMENT OF SEBORRHEIC DERMATITIS.

  • USE

    Dermoscribe's Seborrheic Dermatitis Cream is a topical treatment for relief of the symptoms and signs of Seborrheic Dermatitis.

  • WARNINGS

    FOR EXTERNAL USE ONLY. Avoid contact with mouth, eyes and anal skin.
    Do not swallow. Seek medical advice before using if pregnant or breastfeeding. If irritation
    develops, stop using and seek medical advice. May not be as effective after expiry date.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • DIRECTIONS

    For use only by persons over 12 years old. Apply in a thin layer over the affected area once or twice daily as required.

    Use only in accordance with the directions on the label and within the packaging. Refer to enclosed leaflet for detailed directions.

  • INACTIVE INGREDIENTS

    AQUEOUS CREAM

  • OTHER SAFETY INFORMATION

    STORE AT ROOM TEMPERATURE

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Seb Dermatitis Tube Label 113mm x 89mm FINAL ARTWORK

  • INGREDIENTS AND APPEARANCE
    DERMOSCRIBE SEBORRHEIC DERMATITIS 
    sulfur, salicylic acid, hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69683-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR3 g  in 100 g
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID3 g  in 100 g
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCOL STEARATE SE (UNII: 6YLY96TQL6)  
    SORBITOL (UNII: 506T60A25R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69683-202-1160 g in 1 BOTTLE; Type 0: Not a Combination Product03/23/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/23/2015
    Labeler - DERMOSCRIBE PTY LTD (742164734)
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