FDA label 2a82d83a-3f92-4c0c-bb28-cbc3b0941c12

5 WARNINGS AND PRECAUTIONS • Endocrine System Adverse Reactions: • Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency. Consider periodic evaluations for HPA axis suppression if LOCOID Lotion is applied to large surface areas or used under occlusion. If HPA axis suppression is noted, reduce the application frequency, discontinue use, or switch to a lower potency corticosteroid. ( 5.1 , 8.4 ) • Systemic effects of topical corticosteroids may also include manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria. ( 5.1 , 8.4 ) • Pediatric patients may be more susceptible to systemic toxicity due to their larger skin-surface-to-body-mass ratios. ( 5.1 , 8.4 ) • Ophthalmic Adverse Reactions: Topical corticosteroids, including LOCOID Lotion, may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. ( 5.2 ) • Skin Infections: Initiate appropriate therapy if concomitant skin infections develop. ( 5.3 ) 5.1 Endocrine System Adverse Reactions Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression Use of topical corticosteroids, including LOCOID Lotion, can cause systemic adverse reactions including reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Such patients should be considered for periodic evaluation of the HPA axis. This may be done by using cosyntropin (ACTH 1-24 ) stimulation testing (CST). If HPA axis suppression is noted, reduce the frequency of application or discontinue LOCOID Lotion, or substitute with a less potent corticosteroid. Signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids [see Adverse Reactions (6) ] . Studies conducted in pediatric subjects demonstrated reversible HPA axis suppression after use of LOCOID Lotion. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of LOCOID Lotion due to their larger skin-surface-to-body-mass ratios [see Use in Specific Populations (8.4) ]. Cushing’s Syndrome, Hyperglycemia, and Glucosuria Systemic adverse reactions of topical corticosteroids, including LOCOID Lotion, may also include manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria. Additional Considerations for Endocrine Adverse Reactions Use of more than one corticosteroid-containing product at the same time may increase total systemic corticosteroid exposure. Minimize systemic corticosteroid adverse reactions by mitigating the risk factors for increased systemic absorption and using LOCOID Lotion as recommended [see Dosage and Administration (2) ] . 5.2 Ophthalmic Adverse Reactions Use of topical corticosteroids, including LOCOID Lotion, may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in post-marketing experience with the use of topical corticosteroid products [see Adverse Reactions (6.2) ] . Avoid contact of LOCOID Lotion with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation. 5.3 Skin Infections Use of topical corticosteroids, including LOCOID Lotion, may delay healing or worsen concomitant skin infections. If skin infections are present or develop, an appropriate antimicrobial agent should be used. If a favorable response does not occur promptly, use of LOCOID Lotion should be discontinued until the infection has been adequately controlled [see Adverse Reactions (6) ]. 5.4 Allergic Contact Dermatitis Use of topical corticosteroids, including LOCOID Lotion, can cause allergic contact dermatitis [see Adverse Reactions (6) ] . Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noticing a clinical exacerbation. Such an observation should be corroborated with appropriate patch testing. Discontinue LOCOID Lotion if the diagnosis is established .

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • HPA axis suppression [see Warnings and Precautions (5.1) , Use in Specific Populations (8.4) ] • Ophthalmic Adverse Reactions [see Warnings and Precautions (5.2 )] • Skin infections [see Warnings and Precautions (5.3) ] • Allergic contact dermatitis [see Warnings and Precautions (5.4) ] The most common adverse reactions (>1%) are application site reactions. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 and/or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described below reflect exposure to LOCOID Lotion applied topically twice daily for up to 4 weeks in vehicle-controlled clinical trials of 284 pediatric subjects 3 months to 18 years of age and 301 adult subjects with mild to moderate atopic dermatitis [see Clinical Studies (14) ] . The incidence of selected adverse reactions reported by ≥1% of subjects during the studies is presented in Table 1 and Table 2. Table 1. Adverse Reactions in ≥1% of LOCOID Lotion-treated Pediatric Subjects 3 Months to 18 Years of Age with Mild to Moderate Atopic Dermatitis LOCOID Lotion (n=139) n (%) Vehicle (n=145) n (%) Application site reactions, including application site burning, pruritus, dermatitis, erythema, eczema, inflammation, or irritation 2 (1) 20 (14) Infantile acne 1 (1) 0 (0) Skin depigmentation 1 (1) 0 (0) Table 2. Adverse Reactions in ≥1% of LOCOID Lotion-treated Adult Subjects with Mild to Moderate Atopic Dermatitis LOCOID Lotion (n=151) n (%) Vehicle (n=150) n (%) Application site reactions, including application site burning, dermatitis, eczema, erythema, or pruritus 5 (3) 7 (5) 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of topical corticosteroids, including LOCOID Lotion. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Local Adverse Reactions : folliculitis, acneiform eruptions, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria, and telangiectasia. Ophthalmic Adverse Reactions: blurred vision, cataracts, glaucoma, and increased intraocular pressure.

<table ID="_Refb0c6b949-b5ec-4a0f-afe8-9928c878adc5" width="100%"><caption>Table 1. Adverse Reactions in &#x2265;1% of LOCOID Lotion-treated Pediatric Subjects 3 Months to 18 Years of Age with Mild to Moderate Atopic Dermatitis</caption><col width="34%"/><col width="33%"/><col width="33%"/><tbody><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph> </paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold">LOCOID Lotion</content></paragraph><paragraph><content styleCode="bold">(n=139) n (%)</content></paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph><content styleCode="bold">Vehicle</content></paragraph><paragraph><content styleCode="bold">(n=145) n (%)</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Application site reactions, including application site burning, pruritus, dermatitis, erythema, eczema, inflammation, or irritation</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>2 (1)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>20 (14)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Infantile acne</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>1 (1)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0 (0)</paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule " valign="top"><paragraph>Skin depigmentation</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>1 (1)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>0 (0)</paragraph></td></tr></tbody></table>

<table ID="_Refb45e2532-328c-4093-91c0-da547d2ad50c" width="100%"><caption>Table 2. Adverse Reactions in &#x2265;1% of LOCOID Lotion-treated Adult Subjects with Mild to Moderate Atopic Dermatitis</caption><col width="33%"/><col width="33%"/><col width="33%"/><tbody><tr><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph> </paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold">LOCOID Lotion</content></paragraph><paragraph><content styleCode="bold">(n=151) n (%)</content></paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold">Vehicle</content></paragraph><paragraph><content styleCode="bold">(n=150) n (%)</content></paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule " valign="top"><paragraph>Application site reactions, including application site burning, dermatitis, eczema, erythema, or pruritus</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="middle"><paragraph>5 (3)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="middle"><paragraph>7 (5)</paragraph></td></tr></tbody></table>