TINTED ACNE TREATMENT- resorcinol 2.00% sulfur 8.00% cream

Tinted Acne Treatment by

Drug Labeling and Warnings

Tinted Acne Treatment by is a Otc medication manufactured, distributed, or labeled by Walgreens, Product Quest Mfg.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

INDICATIONS & USAGE

Use for the treatment of acne

WARNINGS

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

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TINTED ACNE TREATMENT 
resorcinol 2.00% sulfur 8.00% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-7783
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Resorcinol (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK)	Resorcinol	2 g  in 100 g
Sulfur (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	Sulfur	8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-7783-01	1 in 1 CARTON	09/13/2017
1		18 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	09/13/2017

Labeler - Walgreens (008965063)

Registrant - Product Quest Mfg. (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg.		927768135	manufacture(0363-7783) , label(0363-7783)