REZAMID- sulfur and resorcinol lotion 
Summers Laboratories Inc

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.

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ACTIVE INGREDIENT

SULFUR 5%

RESORCINOL 2%

PURPOSE

ACNE TREATMENT LOTION

USE

DRIES UP ACNE PIMPLES, HELPS PREVENT NEW PIMPLES

WARNINGS

DO NOT USE

WHEN USING THIS PRODUCT

STOP USE AND ASK A DOCTOR IF

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

Directions

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_Unit Carton

REZAMID 
sulfur and resorcinol lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 DescriptionMarketing Start DateMarketing End Date
1NDC:11086-022-111 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/FEIBusiness Operations
Summers Laboratories Inc002382612manufacture(11086-022), pack(11086-022)

Revised: 10/2014
Document Id: 061dad65-c4b2-0be7-e054-00144ff88e88
Set id: d02ace0b-7244-45d4-987f-eb569303a426
Version: 3
Effective Time: 20141023
 
Summers Laboratories Inc