Label: REZAMID- sulfur and resorcinol lotion

  • NDC Code(s): 11086-022-01
  • Packager: Summers Laboratories Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 9, 2023

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  • ACTIVE INGREDIENTS

    SULFUR 5%

    RESORCINOL 2%

  • PURPOSE

    ACNE TREATMENT LOTION

  • USE

    DRIES UP ACNE PIMPLES, HELPS PREVENT NEW PIMPLES

  • WARNINGS

    • FOR EXTERNAL USE ONLY
  • DO NOT USE

    DO NOT USE

    • ON BROKEN SKIN
    • ON LARGE AREAS OF THE BODY
  • WHEN USING

    WHEN USING THIS PRODUCT

    • APPLY TO AFFECTED AREAS ONLY
    • DO NOT GET INTO EYES

    • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time

  • STOP USE

    STOP USE AND ASK A DOCTOR IF

    • IF SKIN IRRITATION OCCURS OR GETS WORSE

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DIRECTIONS

    • shake very well before using
    • clean the skin thoroughly before applying this product
    • cover the entire affected area with a thin layer one to three times daily
    • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
    • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • INACTIVE INGREDIENTS

    water, SD-40 alcohol 28%, zinc oxide, talc, titanium dioxide, propylene glycol, attapulgite, lauramide DEA, iron oxides, sodium bisulfite, PEG-8 laurate, parachlorometaxylenol, hydroxyethylcellulose, sodium chloride, sodium polynapthalene sulfonate, EDTA, methyl paraben, xanthan gum, butylparaben, fragrance, simethicone.

  • PRINCIPAL DISPLAY PANEL

    Rezamid_Unit Carton

  • INGREDIENTS AND APPEARANCE
    REZAMID 
    sulfur and resorcinol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11086-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR5 g  in 100 mL
    RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ATTAPULGITE (UNII: U6V729APAM)  
    LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SODIUM BISULFITE (UNII: TZX5469Z6I)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM NAPHTHALENESULFONATE (UNII: D3F8YRX7TP)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON (UNII: Z4152N8IUI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11086-022-0156.7 mL in 1 BOTTLE; Type 0: Not a Combination Product10/30/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03210/30/2013
    Labeler - Summers Laboratories Inc (002382612)
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