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REZAMID

Dosage form: lotion
Ingredients: SULFUR 5g in 100mL, RESORCINOL 21 in 100mL
Labeler: Summers Laboratories Inc
NDC Code: 11086-022

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.

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

  • ON BROKEN SKIN
  • ON LARGE AREAS OF THE BODY

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 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.

REZAMID 
sulfur and resorcinol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11086-022
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (SULFUR) SULFUR5 g  in 100 mL
RESORCINOL (RESORCINOL) RESORCINOL2   in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL28 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 CodePackage Description
1NDC:11086-022-111 BOTTLE in 1 BOX
1NDC:11086-022-0156.7 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D10/30/2013
Labeler - Summers Laboratories Inc (002382612)
Establishment
NameAddressID/FEIOperations
Summers Laboratories Inc002382612manufacture(11086-022), pack(11086-022)

Revised: 09/2017
 
Summers Laboratories Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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