OTC Medication Information: Tinted Acne Treatment

TINTED ACNE TREATMENT- resorcinol and sulfur 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.

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 DioxideWater

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Resorcinol (RESORCINOL) Resorcinol 2 g in 100 g
Sulfur (SULFUR) Sulfur 8 g in 100 g
Inactive Ingredients
Ingredient Name Strength
Water
ALCOHOL
Bentonite
GLYCERYL STEARATE SE
Propylene Glycol
Isopropyl Myristate
Methylparaben
Propylparaben
Titanium Dioxide
FERROUS OXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-7783-01 1 TUBE in 1 CARTON contains a TUBE
1 18 g in 1 TUBE This package is contained within the CARTON (0363-7783-01)
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 Operations
Product Quest Mfg. 927768135 manufacture (0363-7783), label (0363-7783)

Revised: 05/2018 Walgreens

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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