Indications and uses
AZELEX ® Cream is indicated for the topical treatment of mild-to-moderate inflammatory acne vulgaris.
AZELEX® (azelaic acid cream) 20%
- Manufacturer
- Physicians Total Care, Inc.
- Effective date
- 2012-06-11
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 20:15:21
Label at a glance#
ProductAZELEX
Active ingredientazelaic acid
Label structure11 sections
Dosage and administration
After the skin is thoroughly washed and patted dry, a thin film of AZELEX ® Cream should be gently but thoroughly massaged into the affected areas twice daily, in the morning and evening. The hands should be washed following application. The duration of use of AZELEX ® Cream can vary from person to person and depends on the severity of the acne. Improvement of the condition occurs in the majority of patients with ...
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
For Dermatologic Use Only
Not for Ophthalmic Use
DESCRIPTION
AZELEX® (azelaic acid cream) 20% contains azelaic acid, a naturally occurring saturated dicarboxylic acid.
Structural Formula: HOOC-(CH2)7-COOH
Chemical Name: 1,7-heptanedicarboxylic acid
Empirical Formula: C9H16O4
Molecular Weight: 188.22
SPL UNCLASSIFIED SECTION
Active Ingredient: Each gram of AZELEX® contains azelaic acid......... 0.2 gm (20% w/w).
SPL UNCLASSIFIED SECTION
Inactive Ingredients: cetearyl octanoate; glycerin; glyceryl stearate and cetearyl alcohol and cetyl palmitate and cocoglycerides; PEG-5 glyceryl stearate; propylene glycol; and purified water. Benzoic acid is present as a preservative.
CLINICAL PHARMACOLOGY
The exact mechanism of action of azelaic acid is not known. The following in vitro data are available, but their clinical significance is unknown. Azelaic acid has been shown to possess antimicrobial activity against Propionibacterium acnes and Staphylococcus epidermidis. The antimicrobial action may be attributable to inhibition of microbial cellular protein synthesis.
A normalization of keratinization leading to an anticomedonal effect of azelaic acid may also contribute to its clinical activity. Electron microscopic and immunohistochemical evaluation of skin biopsies from human subjects treated with AZELEX® Cream demonstrated a reduction in the thickness of the stratum corneum, a reduction in number and size of keratohyalin granules, and a reduction in the amount and distribution of filaggrin (a protein component of keratohyalin) in epidermal layers. This is suggestive of the ability to decrease microcomedo formation.
PHARMACOKINETICS SECTION
Pharmacokinetics: Following a single application of AZELEX® Cream to human skin in vitro, azelaic acid penetrates into the stratum corneum (approximately 3 to 5% of the applied dose) and other viable skin layers (up to 10% of the dose is found in the epidermis and dermis). Negligible cutaneous metabolism occurs after topical application. Approximately 4% of the topically applied azelaic acid is systemically absorbed. Azelaic acid is mainly excreted unchanged in the urine but undergoes some β-oxidation to shorter chain dicarboxylic acids. The observed half-lives in healthy subjects are approximately 45 minutes after oral dosing and 12 hours after topical dosing, indicating percutaneous absorption rate-limited kinetics.
Azelaic acid is a dietary constituent (whole grain cereals and animal products), and can be formed endogenously from longer-chain dicarboxylic acids, metabolism of oleic acid, and ψ-oxidation of monocarboxylic acids. Endogenous plasma concentration (20 to 80 ng/mL) and daily urinary excretion (4 to 28 mg) of azelaic acid are highly dependent on dietary intake. After topical treatment with AZELEX® Cream in humans, plasma concentration and urinary excretion of azelaic acid are not significantly different from baseline levels.
INDICATIONS AND USAGE
AZELEX® Cream is indicated for the topical treatment of mild-to-moderate inflammatory acne vulgaris.
CONTRAINDICATIONS
AZELEX® Cream is contraindicated in individuals who have shown hypersensitivity to any of its components.
WARNINGS
AZELEX® Cream is for dermatologic use only and not for ophthalmic use.
There have been isolated reports of hypopigmentation after use of azelaic acid. Since azelaic acid has not been well studied in patients with dark complexions, these patients should be monitored for early signs of hypopigmentation.
PRECAUTIONS
General:
If sensitivity or severe irritation develop with the use of AZELEX® Cream, treatment should be discontinued and appropriate therapy instituted.
Information for patients:
Patients should be told:
- To use AZELEX® Cream for the full prescribed treatment period.
- To avoid the use of occlusive dressings or wrappings.
- To keep AZELEX® Cream away from the mouth, eyes and other mucous membranes. If it does come in contact with the eyes, they should wash their eyes with large amounts of water and consult a physician if eye irritation persists.
- If they have dark complexions, to report abnormal changes in skin color to their physician.
- Due in part to the low pH of azelaic acid, temporary skin irritation (pruritus, burning, or stinging) may occur when AZELEX® Cream is applied to broken or inflamed skin, usually at the start of treatment. However, this irritation commonly subsides if treatment is continued. If it continues, AZELEX® Cream should be applied only once-a-day, or the treatment should be stopped until these effects have subsided. If troublesome irritation persists, use should be discontinued, and patients should consult their physician.
Carcinogenesis, mutagenesis, impairment of fertility:
Azelaic acid is a human dietary component of a simple molecular structure that does not suggest carcinogenic potential, and it does not belong to a class of drugs for which there is a concern about carcinogenicity. Therefore, animal studies to evaluate carcinogenic potential with AZELEX® Cream were not deemed necessary. In a battery of tests (Ames assay, HGPRT test in Chinese hamster ovary cells, human lymphocyte test, dominant lethal assay in mice), azelaic acid was found to be nonmutagenic. Animal studies have shown no adverse effects on fertility.
Pregnancy:
Teratogenic Effects: Pregnancy Category B.
Embryotoxic effects were observed in Segment I and Segment II oral studies with rats receiving 2500 mg/kg/day of azelaic acid. Similar effects were observed in Segment II studies in rabbits given 150 to 500 mg/kg/day and in monkeys given 500 mg/kg/day. The doses at which these effects were noted were all within toxic dose ranges for the dams. No teratogenic effects were observed. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers:
Equilibrium dialysis was used to assess human milk partitioning in vitro. At an azelaic acid concentration of 25 μg/mL, the milk/plasma distribution coefficient was 0.7 and the milk/buffer distribution was 1.0, indicating that passage of drug into maternal milk may occur. Since less than 4% of a topically applied dose is systemically absorbed, the uptake of azelaic acid into maternal milk is not expected to cause a significant change from baseline azelaic acid levels in the milk. However, caution should be exercised when AZELEX® Cream is administered to a nursing mother.
Pediatric Use:
Safety and effectiveness in pediatric patients under 12 years of age have not been established.
Geriatric Use:
Clinical studies of AZELEX® Cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
ADVERSE REACTIONS
During U.S. clinical trials with AZELEX®Cream, adverse reactions were generally mild and transient in nature. The most common adverse reactions occurring in approximately 1-5% of patients were pruritus, burning, stinging and tingling. Other adverse reactions such as erythema, dryness, rash, peeling, irritation, dermatitis, and contact dermatitis were reported in less than 1% of subjects. There is the potential for experiencing allergic reactions with use of AZELEX®Cream.
In patients using azelaic acid formulations, the following additional adverse experiences have been reported rarely: worsening of asthma, vitiligo depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris), and exacerbation of recurrent herpes labialis.
DOSAGE AND ADMINISTRATION
After the skin is thoroughly washed and patted dry, a thin film of AZELEX® Cream should be gently but thoroughly massaged into the affected areas twice daily, in the morning and evening. The hands should be washed following application. The duration of use of AZELEX® Cream can vary from person to person and depends on the severity of the acne. Improvement of the condition occurs in the majority of patients with inflammatory lesions within four weeks.
HOW SUPPLIED
AZELEX® Cream is supplied in a closed orifice tube with a white, spiked screwcap in the following sizes:
30 g - NDC 54868-4442-0
Note: Protect from freezing. Store product on its side.
Store between 15° - 30° C (59° - 86° F).
Rx Only.
Distributed by:
Irvine, California 92612, U.S.A.
©2004 Allergan, Inc.
Made in Italy
8466X
Distributed under license.
® Mark of Allergan, Inc.
Revised May 2004
70896US15P
Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 54868-4442-0
AZELEX®
(azelaic acid cream) 20%
For Dermatologic Use Only
Not for Ophthalmic Use
Rx Only
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1041520 | azelaic acid 20 % Topical Cream | PSN | 1 |
| 1043753 | Azelex 20 % Topical Cream | PSN | 1 |
| 1043753 | azelaic acid 200 MG/ML Topical Cream [Azelex] | SBD | 1 |
| 1041520 | azelaic acid 200 MG/ML Topical Cream | SCD | 1 |
| 1041520 | azelaic acid 20 % Topical Cream | SY | 1 |
| 1043753 | Azelex 20 % Topical Cream | SY | 1 |
| 1043753 | Azelex 200 MG/ML Topical Cream | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| AZELAIC ACID Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 6c6fc281-9445-2e9e-1c29-a09ddbc4299c | Product name | 2 | 20200213 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 2a856070-cbe7-4f85-be0f-09885ff91196 | Product name | 1 | 20150806 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 54868-4442-0 | 2019-09-24 | C162847 | 48780-1 | 9350213a-4469-c013-e053-90daa90a1393 | AZELEX® (azelaic acid cream) 20% |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54868-4442-0 | AZELEX | 1 in 1 CARTON | CREAM | 1 | 1 | |
| 54868-4442-0 | AZELEX | 30 g in 1 TUBE | CREAM | 30 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 54868-4442 | AZELEX (AZELAIC ACID) CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | 2 package rows | 20120621_0d5269d5-6555-4d2c-bc3b-df862b014275.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54868-4442-0 | GM - Gram | 54868-4442 | 3aec014a-2f08-4fd3-b104-3b336f90c6a7 | 1 | 2012-07-24 |
| 0023-8694-30 | GM - Gram | 0023-8694 | 984b2708-768a-4b40-8485-f43840b13a44 | 1 | 2013-02-13 |
| 0023-8694-50 | GM - Gram | 0023-8694 | 9c7604d2-c197-44fb-98a5-5e7eb2067382 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| azelaic acid | ACTIVE INGREDIENT | F2VW3D43YT | 1 | |
| azelaic acid | ACTIVE MOIETY | F2VW3D43YT | 1 | |
| benzoic acid | INACTIVE INGREDIENT | 8SKN0B0MIM | 1 | |
| cetearyl ethylhexanoate | INACTIVE INGREDIENT | 9M64UO4C25 | 1 | |
| cetostearyl alcohol | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| cetyl palmitate | INACTIVE INGREDIENT | 5ZA2S6B08X | 1 | |
| coco-glycerides | INACTIVE INGREDIENT | ISE9I7DNUG | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| glyceryl monostearate | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- AZELEX
- azelaic acid
- cetearyl ethylhexanoate
- glycerin
- cetostearyl alcohol
- cetyl palmitate
- propylene glycol
- water
- glyceryl monostearate
- coco-glycerides
- benzoic acid
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54868-4442 | 54868-4442-0 |
| 0023-8694 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| azelaic acid | F2VW3D43YT | ACTIB |
| cetearyl ethylhexanoate | 9M64UO4C25 | IACT |
| glycerin | PDC6A3C0OX | IACT |
| cetostearyl alcohol | 2DMT128M1S | IACT |
| cetyl palmitate | 5ZA2S6B08X | IACT |
| propylene glycol | 6DC9Q167V3 | IACT |
| water | 059QF0KO0R | IACT |
| glyceryl monostearate | 230OU9XXE4 | IACT |
| coco-glycerides | ISE9I7DNUG | IACT |
| glyceryl monostearate | 230OU9XXE4 | IACT |
| benzoic acid | 8SKN0B0MIM | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | SUPPOSITORY / RECTAL | 35 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, DELAYED RELEASE / ORAL | 1.7 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SHAMPOO / TOPICAL | 5 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| glycerin | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL, METERED / TOPICAL | 1225 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY, METERED / NASAL | 240 mg | ||
| benzoic acid | BENZOIC ACID | 8SKN0B0MIM | TABLET, COATED / ORAL | NA | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SWAB / TOPICAL | 34.6 %w/w | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / TOPICAL | 1800 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | LIQUID / TOPICAL | 1 %w/w | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED / ORAL | 25 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | PASTE / DENTAL | 0.5 %w/w | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | OINTMENT / TOPICAL | 5 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, EXTENDED RELEASE / TRANSDERMAL | 58.13 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAMUSCULAR | 4000 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| cetostearyl alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | TABLET, EXTENDED RELEASE / ORAL | 800 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO / TOPICAL | 8 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| benzoic acid | BENZOIC ACID | 8SKN0B0MIM | SOLUTION / TOPICAL | 0.1 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / SUBCUTANEOUS | 15 %w/v | ||
| glycerin | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / TOPICAL | 1971 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / SUBCUTANEOUS | 450 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / SUBCUTANEOUS | 1.4 %w/v | ||
| glycerin | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TRANSDERMAL | 500 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAMUSCULAR | 7459 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / RECTAL | 440 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / RESPIRATORY (INHALATION) | 25 %w/w | ||
| benzoic acid | BENZOIC ACID | 8SKN0B0MIM | INJECTION / INTRAMUSCULAR | 5 %w/v | ||
| benzoic acid | BENZOIC ACID | 8SKN0B0MIM | MOUTHWASH / BUCCAL | NA | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | LOTION / TOPICAL | 177 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / VAGINAL | 750 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | JELLY / TOPICAL | 20 %w/w | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM / BUCCAL | 1.48 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, EMULSION / INTRAVENOUS | 24100 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / NASAL | 5 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / RECTAL | 1214 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION, EXTENDED RELEASE / ORAL | 2000 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, EXTENDED RELEASE / ORAL | 9 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAVENOUS | 4000 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, SOLUBLE / BUCCAL | 5 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / ORAL | 29008 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / OPHTHALMIC | 0.44 %w/w |
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020428-001 | AZELEX | AZELAIC ACID | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020428-001 | AZELEX | 20% | CREAM / TOPICAL | RLD, RS | 1995-09-13 | 3a93d1ddd44b… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 0a0a3e7e-68d9-4201-bd3d-4fe0d7caf35b | 0d5269d5-6555-4d2c-bc3b-df862b014275 | 2012-06-11 | Warnings, Adverse reactions | 0a0a3e7e-68d9-4201-bd3d-4fe0d7caf35b 0d5269d5-6555-4d2c-bc3b-df862b014275 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.