Label: TINTED ACNE TREATMENT- resorcinol 2.00% sulfur 8.00% cream
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated May 1, 2018
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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
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
- 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)