Label: REZAMID- sulfur and resorcinol lotion

  • NDC Code(s): 11086-022-01, 11086-022-11
  • Packager: Summers Laboratories Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    SULFUR 5%

    RESORCINOL 2%

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  • PURPOSE

    PURPOSE

    ACNE TREATMENT LOTION

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  • INDICATIONS & USAGE

    USE

    DRIES UP ACNE PIMPLES, HELPS PREVENT NEW PIMPLES

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  • WARNINGS

    WARNINGS

    • FOR EXTERNAL USE ONLY
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  • DO NOT USE

    DO NOT USE

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

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  • 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.

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  • DOSAGE & ADMINISTRATION

    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
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  • INACTIVE INGREDIENT

    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.

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  • INGREDIENTS AND APPEARANCE
    REZAMID 
    sulfur and resorcinol lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11086-022
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SULFUR (SULFUR) SULFUR 5 g  in 100 mL
    RESORCINOL (RESORCINOL) RESORCINOL 2   in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ALCOHOL 28 mL  in 100 mL
    ZINC OXIDE  
    TALC  
    TITANIUM DIOXIDE  
    PROPYLENE GLYCOL  
    ATTAPULGITE  
    LAURIC DIETHANOLAMIDE  
    FERRIC OXIDE RED  
    SODIUM BISULFITE  
    PEG-8 LAURATE  
    CHLOROXYLENOL  
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)  
    SODIUM CHLORIDE  
    SODIUM NAPHTHALENESULFONATE  
    EDETIC ACID  
    METHYLPARABEN  
    XANTHAN GUM  
    BUTYLPARABEN  
    DIMETHICONE  
    SILICON  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11086-022-11 1 in 1 BOX
    1 NDC:11086-022-01 56.7 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 10/30/2013
    Labeler - Summers Laboratories Inc (002382612)
    Establishment
    Name Address ID/FEI Business Operations
    Summers Laboratories Inc 002382612 manufacture(11086-022), pack(11086-022)
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