Label: REZAMID- sulfur and resorcinol lotion

  • NDC Code(s): 11086-022-01
  • Packager: Summers Laboratories Inc
  • 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 July 14, 2021

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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   in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M) 28 mL  in 100 mL
    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 finalpart333D10/30/2013
    Labeler - Summers Laboratories Inc (002382612)