Clinical Information
Gen. Code and Des.
78800 tretinoin TOPICAL LOTION 0.05 %
GCN and Des.
45194 tretinoin TOPICAL LOTION 0.05 %
Strength
0.05%
Dose Form
LOTION (GRAM)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
84160000 CELL STIMULANTS AND PROLIFERANTS
Active Ingredients
1954 tretinoin 302794
Inactive Ingredients
3192 benzyl alcohol 100516
3203 paraben 99967
9278 fish derived
These highlights do not include all the information needed to use ALTRENO safely and effectively. See full prescribing information for ALTRENO.
ALTRENO® (tretinoin) lotion, for topical use
Initial U.S. Approval: 1973
INDICATIONS AND USAGE
ALTRENO is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. (1)
DOSAGE AND ADMINISTRATION
•
Apply a thin layer of ALTRENO to affected areas once daily. Avoid eyes, mouth, paranasal creases, and mucous membranes. (2)
•
Not for ophthalmic, oral, or intravaginal use. (2)
DOSAGE FORMS AND STRENGTHS
Lotion, 0.05% (3)
Each gram of ALTRENO contains 0.5 mg (0.05%) tretinoin. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•
Skin Irritation: Dryness, pain, erythema, irritation and exfoliation may occur with use of ALTRENO. (5.1)
•
Ultraviolet Light and Environmental Exposure: Minimize exposure to sunlight and sunlamps. Use sunscreen and protective clothing when sun exposure cannot be avoided. (5.2)
•
Fish Allergies: Use ALTRENO with caution if allergic to fish due to potential for allergenicity to fish protein. Advise patients to contact their healthcare provider if they develop pruritus or urticaria. (5.3)
ADVERSE REACTIONS
•
The most common adverse reactions occurring in ≥1% of subjects and greater than vehicle were dryness, pain, erythema, irritation and exfoliation (all at the application site). (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.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 3/2020
