BD Micro Fine Plus Insulin Syringe

RETIN-A MICRO ® is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. RETIN-A MICRO is a retinoid indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. ( 1)

• For topical use only
• Not for oral, ophthalmic, or intravaginal use. • Prior to RETIN-A MICRO use, thoroughly cleanse area(s) with a mild, non-medicated cleanser then pat the skin dry. • When applying RETIN-A MICRO, keep away from the eyes, the mouth, paranasal creases of the nose, and mucous membranes. • Apply a thin layer of RETIN-A MICRO (0.04%, 0.06%, 0.08%, or 0.1%) to skin where acne lesions appear (cover the entire affected area), once daily in the evening
• Do not apply more than a thin layer [see Warning and Precautions ]
• Improvements in acne lesions may be noticed after two weeks of RETIN-A MICRO therapy, but more than seven weeks of therapy may be needed for sustained benefit
• If RETIN-A MICRO was temporarily discontinued due to local adverse reactions, RETIN-A MICRO therapy may be resumed upon resolution of local adverse reactions. • For topical use only
• Not for oral, ophthalmic, or intravaginal use. • Keep away from eyes, mouth, paranasal creases of the nose, and mucous membranes. • Apply a thin layer of RETIN-A MICRO to skin where acne lesions appear (cover the entire affected area) (0.04%, 0.06%, 0.08%, or 0.1%) once daily in the evening

Gel (white to very pale yellow and opaque): • 0.04% (0.4 mg of tretinoin per gram) • 0.06% (0.6 mg of tretinoin per gram) • 0.08% (0.8 mg of tretinoin per gram) • 0.1% (1 mg of tretinoin per gram). Gel: 0.04%, 0.06%, 0.08%, and 0.1% ( 3 )

• The safety and effectiveness of RETIN-A MICRO for topical application
• For the treatment of acne vulgaris have been established
• In pediatric patients aged 12 years and older [see Clinical Studies ]
• The safety and effectiveness of RETIN-A MICRO have not been established
• In pediatric patients younger than 12 years of age

Clinical trials of RETIN-A MICRO did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger adult subjects. Acne vulgaris is largely a disease of pediatric and young adult patients. Clinical studies of RETIN-A MICRO did not include patients 65 years of age and older.

• Advise the patient to read the FDA-approved patient labeling (Patient Information)
• Administration Instruct the patient to [see Dosage and Administration ] : • Thoroughly cleanse treatment area(s) with a mild, non-medicated cleanser then pat the skin dry prior to application of RETIN-A MICRO. • Avoid contact with eyes, mouth, paranal creases of nose, and mucous membranes when applying RETIN-A MICRO. • Apply a thin layer of RETIN-MICRO to cover the affected area(s). …

• None
• None

• Local Skin Irritation : RETIN-A MICRO can cause local skin irritation, including excessive dryness, redness, swelling, peeling, itching, blistering, burning, or stinging ( 5.1 ) • Avoid use on eczematous skin or during weather extremes, such as severe wind or cold. • To reduce the risk of local skin irritation, wash the treated skin gently, using a mild, non-medicated soap, avoid washing the treated skin too often or scrubbing it hard when washing, and apply a topical moisturizer. • If severe local skin irritation occurs, discontinue use temporarily or permanently. …

Most common adverse reactions were skin irritation, skin burning, erythema, peeling, dryness, itching, and dermatitis. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 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. …

8.1 Pregnancy Risk Summary Available data from published prospective observational studies and retrospective cohort studies over decades of use of topical tretinoin in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . …

Oral ingestion of large amounts of RETIN-A MICRO may lead to the same adverse reactions as those associated with excessive oral intake of Vitamin A. Consider contacting the Poison Help Line (1-800-222-1222) or a medical toxicologist for overdose recommendations.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.