Active Ingredients
Benzoyl Peroxide 10%
Differin 10% Bpo Acne Treatment Solution
FDA Label NDC 0299-4611
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Galderma Laboratories, L.p. for the product Differin 10% Bpo Acne Treatment (NDC 0299-4611). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Acne treatment
Uses
For the treatment of acne
Warnings
For external use only.
Do not use if you
■ have very sensitive skin
■ are sensitive to benzoyl peroxide
When using this product
■ 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.
■ avoid unnecessary sun exposure and use a sunscreen
■ avoid contact with the eyes, lips, and mouth
■ avoid contact with hair and dyed fabrics, which may be bleached by this product
■ 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
■ irritation becomes severe.
Otc - 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.
Directions
• Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below ■ 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 ■ if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor
Inactive Ingredients
Acrylates Copolymer, Carbomer, Diethylhexyl Sodium Sulfosuccinate, Disodium EDTA, Glycerin, Poloxamer 182, Propylene Glycol, Silica, Sodium Hydroxide, Water
Questions Or Comments?
1-866-735-4137
Otc - Questions
Distributed by:
Galderma Laboratories, L.P.
Dallas, TX 75201
USA
All trademarks are the property of their respective owners
Made in Canada
www.differin.com
Principle Display Panel - 1 Oz (28 G) Carton
NEW
DIFFERIN®
Acne
Spot
Treatment
10%
BENZOYL
PEROXIDE
Acne Treatment
MAXIMUM STRENGTH
Reduces Acne Size & Redness
VISIBLE RESULTS AFTER 1 DAY
NET WT 1 OZ (28 g)
P57672-0
* Please review the disclaimer below.
