Tazorac 1 mg/g
tazarotene · GEL · Almirall, LLC
Tazorac is a gel containing tazarotene at 1 mg/g, taken cutaneous. Manufactured by Almirall, LLC.
Key Facts
- Brand Name
- Tazorac
- Generic Name
- tazarotene
- NDC Code (Product)
16110-042- Manufacturer
- Almirall, LLC
- Strength
- 1 mg/g
- Dosage Form
- GEL
- Route
- CUTANEOUS
- Marketing Status
- Application #
- NDA020600
- Drug Class
- Retinoid [EPC]
- Marketing Start
- 02/21/2020
Recall History
Allergan Sales, LLC
Failed Content Uniformity Specifications.
Allergan Sales, LLC
Failed Content Uniformity Specifications
Allergan Sales, LLC
Failed Content Uniformity Specifications
Allergan Sales, LLC
Failed Content Uniformity Specifications.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE TAZORAC ® Cream 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis. ( 1.1 ) TAZORAC Cream 0.1% is indicated for the topical treatment of acne vulgaris. ( 1.2 ) 1.1 Plaque Psoriasis TAZORAC ® (tazarotene) Cream, 0.05% and 0.1% are indicated for the topical treatment of patients with plaque psoriasis. 1.2 Acne Vulgaris TAZORAC (tazarotene) Cream, 0.1% is also indicated for the topical treatment of patients with acne vulgaris.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Apply a thin layer of TAZORAC Cream only to the affected area once daily in the evening. ( 2.1 , 2.2 ) Not for ophthalmic, oral, or intravaginal use. ( 2.2 ) If contact with eyes occurs, rinse thoroughly with water. ( 2.2 ) 2.1 Important Administration Instructions TAZORAC Cream is for topical use only. TAZORAC Cream is not for ophthalmic, oral, or intravaginal use. If contact with mucous membranes occurs, rinse thoroughly with water [see Warnings and Precaution ( 5.2 )] . Wash hands thoroughly after application. 2.2 Psoriasis It is recommended that treatment starts with TAZORAC Cream, 0.05%, with strength increased to 0.1% if tolerated and medically indicated. Apply a thin film (2 mg/cm 2 ) of TAZORAC Cream once per day, in the evening, to cover only the psoriatic lesions. If a bath or shower is taken prior to application, the skin should be dry before applying the cream. If emollients are used, they should be applied at least an hour before application of TAZORAC Cream. Because unaffected skin may be more susceptible to irritation, application of TAZORAC Cream to these areas should be carefully avoided. 2.3 Acne Cleanse the face gently. After the skin …
Contraindications
4 CONTRAINDICATIONS TAZORAC Cream is contraindicated in: Pregnancy. Retinoids may cause fetal harm when administered to a pregnant female [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 , 8.3 )] . Individuals who have known hypersensitivity to any of its components [see Warnings and Precautions ( 5.2 )] . Pregnancy ( 4 , 8.1 ) Hypersensitivity ( 4 )
Drug Interactions
7 DRUG INTERACTIONS No formal drug-drug interaction studies were conducted with TAZORAC Cream. In a trial of 27 healthy female subjects between the ages of 20–55 years receiving a combination oral contraceptive tablet containing 1 mg norethindrone and 35 mcg ethinyl estradiol, concomitant use of tazarotene administered as 1.1 mg orally (mean ± SD C max and AUC 0-24 of tazarotenic acid were 28.9 ± 9.4 ng/mL and 120.6 ± 28.5 ng • hr/mL) did not affect the pharmacokinetics of norethindrone and ethinyl estradiol over a complete cycle. The impact of tazarotene on the pharmacokinetics of progestin only oral contraceptives (i.e., minipills) has not been evaluated.
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in more detail in other sections of the labeling: Embryofetal toxicity [see Warnings and Precautions ( 5.1 )] Photosensitivity and Risk of Sunburn [see Warnings and Precautions ( 5.3 )] Plaque psoriasis: Most common adverse reactions occurring in 10 to 23% of patients are pruritus, erythema, and burning. ( 6.1 ) Acne Vulgaris: Most common adverse reactions occurring in 10 to 30% of patients are desquamation, dry skin, erythema, and burning sensation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-678-1605 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 clinical practice. In human dermal safety trials, TAZORAC Cream, 0.05% and 0.1% did not induce allergic contact sensitization, phototoxicity, or photoallergy. Psoriasis The most frequent adverse reactions reported with TAZORAC Cream, 0.05% and 0.1% occu…
Frequently Asked Questions
What is Tazorac used for?
Tazorac contains tazarotene. It is a gel taken cutaneous. Consult your doctor for specific uses.
Is Tazorac a controlled substance?
Tazorac is not classified as a controlled substance by the DEA.
What is the generic name for Tazorac?
The generic name for Tazorac is tazarotene. There are 11 other brand versions of tazarotene.
What is the NDC code for Tazorac 1 mg/g?
The NDC (National Drug Code) for Tazorac 1 mg/g is 16110-042, listed by Almirall, LLC.