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 Type HUMAN OTC DRUG Item Code (Source) NDC:11086-022
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 5 g  in 100 mL
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL 2   in 100 mL
Inactive Ingredients
Ingredient Name Strength
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 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)

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