REZAMID- sulfur and resorcinol lotion

REZAMID by

Drug Labeling and Warnings

REZAMID by is a Otc medication manufactured, distributed, or labeled by Summers Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

REZAMID 
sulfur and resorcinol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11086-022
Route of Administration	TOPICAL

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: 11086-022-01	56.7 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/30/2013

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)