ed 50 grams per week [see Dosage and Administration (2)].
Instruct patients to avoid bandaging, wrapping or otherwise occluding the treatment area(s), unless directed by physician. Advisepatients to avoid use on the face, groin, or axillae [see Dosage and Administration (2)].
Inform patients that DUOBRII Lotion is for external use only. Advise patients that DUOBRII Lotion is not for oral, ophthalmic, or
intravaginal use [see Dosage and Administration (2)].
Fetal risk is associated with DUOBRII Lotion for females of reproductive potential. Advise patients to use an effective method ofcontraception during treatment to avoid pregnancy. Advise the patient to stop medication if she becomes pregnant and call her doctor[see Contraindications (4.1), Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].
Breastfeeding women should not apply DUOBRII Lotion directly to the nipple and areola to avoid directly exposing the infant [seeUse in Specific Populations (8.2)].
Avoid exposure of the treated areas to either natural or artificial sunlight, including tanning beds and sunlamps. Use sunscreen andprotective clothing if exposure to sunlight is unavoidable when using DUOBRII Lotion [see Warnings and Precautions (5.3)].
HPA Axis Suppression and Other Unwanted Systemic Glucocorticoid EffectsDUOBRII Lotion may cause HPA axis suppression. Advise patients that use of topical corticosteroids, including DUOBRII Lotion,may require periodic eva luation for HPA axis suppression. Topical corticosteroids may have other endocrine effects. Concomitant useof multiple corticosteroid-containing products may increase the total systemic exposure to topical corticosteroids [see Warnings andPrecautions (5.2)].
Local Adverse Reactions
Inform patients that DUOBRII Lotion may cause local adverse reactions. These reactions may be more likely to occur with occlusiveuse or use of DUOBRII Lotion. If undue irritation (redness, peeling, or discomfort) occurs, reduce frequency of application ortemporarily interrupt treatment. Treatment may be resumed once irritation subsides, unless allergic contact dermatitis is identified [seeWarnings and Precautions (5.3)].
Ophthalmic Adverse Reactions
Advise patients to report any visual symptoms to their healthcare providers.
Manufactured for:
Bausch Health Americas, Inc.
Bridgewater, NJ 08807 USA
By:
Bausch Health Companies Inc.
Laval, Quebec H7L 4A8, Canada
U.S. Patent Numbers: 6,517,847; 8,809,307 and 10,251,895
DUOBRII is a trademark of Bausch Health Companies Inc. or its affiliates.
© 2019 Bausch Health Companies Inc. or its affiliates
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