TINTED ACNE TREATMENT- resorcinol 2.00% sulfur 8.00% cream 
Walgreens

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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Well at Walgreens

Drug Facts

Active ingredient                                                                                                 Purpose
Resorcinol - 2.00%...............................................................................................Acne Treatment
Sulfur - 8.00% .................................................................................................... Acne Treatment

Use for the treatment of acne

Warnings
For external use only
Do not use • if you have very sensitive skin or are sensitive to benzoyl peroxide
When using this product • skin irritation and dryness are 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. • rinse right away with water if it gets in eyes • avoid unnecessary sun exposure and use a sunscreen • avoid contact with the eyes, lips, and mouth • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
Stop use and ask a doctor if skin irritation becomes severe

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions • cleanse the skin thoroughly before applying medication • cover the entire affected area
with a thin layer one to three times a day • 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. • if going
outside, use a sunscreen. Allow product to dry, then follow direction in the sunscreen labeling. If
sensitivity develops, discontinue use of both products and consult a doctor.

Inactive ingredients

Alcohol Denat.
Bentonite
Fragrance
Glyceryl Stearate SE
Iron Oxides
Isopropyl Myristate
Methylparaben
Propylene Glycol
Propylparaben
Simethicone
Titanium Dioxide
Water

image descriptionimage description

TINTED ACNE TREATMENT 
resorcinol 2.00% sulfur 8.00% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-7783
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Resorcinol (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) Resorcinol2 g  in 100 g
Sulfur (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) Sulfur8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Bentonite (UNII: A3N5ZCN45C)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Isopropyl Myristate (UNII: 0RE8K4LNJS)  
Methylparaben (UNII: A2I8C7HI9T)  
Propylparaben (UNII: Z8IX2SC1OH)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
FERROUS OXIDE (UNII: G7036X8B5H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-7783-011 in 1 CARTON09/13/2017
118 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D09/13/2017
Labeler - Walgreens (008965063)
Registrant - Product Quest Mfg. (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg.927768135manufacture(0363-7783) , label(0363-7783)

Revised: 5/2018
Document Id: 3e34a4b1-8e84-4968-9ba3-9e29d0266718
Set id: 30e7d8f7-ca10-436a-8cce-25f97a7163a9
Version: 1
Effective Time: 20180501
 
Walgreens