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Ery
Erythromycin · Swab
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Erythromycin | 20 mg/mL | 197650 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Decreased Sebaceous Gland Activity [PE] | PE | All 37 members |
| Macrolide Antimicrobial [EPC] | EPC | All 31 members |
| Macrolide [EPC] | EPC | All 16 members |
| Macrolides [CS] | CS | All 32 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 064126-001 | ERYTHROMYCIN | SWAB | ERYTHROMYCIN | Prescription | AT | RS |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — bioequivalence demonstrated (topical dermatological products)
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 9 | Labeling | Approved | March 31, 2008 | — |
| Supplement | 6 | Manufacturing (CMC) | Approved | September 16, 2002 | — |
| Supplement | 3 | Manufacturing (CMC) | Approved | February 20, 2002 | — |
| Supplement | 5 | Manufacturing (CMC) | Approved | December 6, 2001 | — |
| Supplement | 4 | Manufacturing (CMC) | Approved | December 6, 2001 | — |
| Supplement | 2 | Manufacturing (CMC) | Approved | November 17, 2000 | — |
| Supplement | 1 | Labeling | Approved | July 11, 1997 | — |
| Original application | 1 | Approved | July 3, 1996 | — |
Review documents
- 0 · Original application · March 10, 2011
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20241224). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingINDICATIONS AND USAGE Ery 2% Pads are indicated for the topical treatment of acne vulgaris.
Dosage and Administration
openFDA Drug LabelingDOSAGE AND ADMINISTRATION The Ery 2% Pads should be rubbed over the affected area twice a day (morning and evening) after skin is thoroughly washed with warm water and soap and patted dry. Acne lesions on the face, neck, shoulders, chest, and back may be treated in this manner. Additional pledgets may be used, if needed. Each pledget should be used once and discarded. Wash hands after application. Close jar tightly after each use. Drying and peeling may be controlled by reducing the frequency of applications.
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS Ery 2% Pads are contraindicated in those individuals who have shown hypersensitivity to any of its components.
Warnings
openFDA Drug LabelingWARNINGS Pseudomembranous colitis has been reported with nearly all antibacterial agents, including erythromycin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of “antibiotic-associated colitis”. After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.
Adverse Reactions
openFDA Drug LabelingADVERSE REACTIONS The following local adverse reactions have been reported occasionally: peeling, dryness, itching, erythema, and oiliness. Irritation of the eyes and tenderness of the skin have also been reported with topical use of erythromycin. Generalized urticarial reactions, possibly related to the use of erythromycin, which required systemic steroid therapy have been reported.
Description
openFDA Drug LabelingDESCRIPTION Ery 2% Pads contain erythromycin, USP for topical dermatologic use. Erythromycin is a macrolide antibiotic produced from a strain of Saccaropolyspora erythraea (formerly Streptomyces erythreus ). It is a base and readily forms salts with acids. Chemically, erythromycin is C 37 H 67 NO 13 . It has the following structural formula: The chemical name for erythromycin is (3 R *,4 S *,5 S *,6 R *,7 R *,9 R *,11 R *,12 R *,13 S *,14 R *)-4-[(2,6-Dideoxy-3- C -methyl-3- O -methyl-α-L- ribo -hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D- xylo -hexopyranosyl]oxy] oxacyclotetradecane-2,10-dione. Erythromycin has the molecular weight of 733.94. It is a white or slightly yellow, crystalline powder, slightly soluble in water, soluble in alcohol, in chloroform, and in ether. It is odorless or practically odorless. It has a pH range between 8.0 and 10.5 in a methanol and water solution prepared by diluting 1 volume of a methanol solution, containing 40 mg per mL, with 19 volumes of water. Each mL of expressible liquid contains 20 mg erythromycin in a base of dehydrated alcohol, propylene glycol and citric acid to adjust pH. Each pledget is filled to contain 0.8 mL of Erythromycin Topical Solution 2%. Chemical structure
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Ery 2% Pads are available as follows: A plastic jar containing 60 pledgets (NDC 72162-1443-6) Each pledget is filled to contain 0.8 mL of Erythromycin Topical Solution 2%. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: ERYTHROMYCIN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 63629-8648-1 | 63629-8648 | Bryant Ranch Prepack | 60 APPLICATOR in 1 JAR (63629-8648-1) / .8 mL in 1 APPLICATOR | July 7, 2008 |
| 72162-1443-6 | 72162-1443 | Bryant Ranch Prepack | 60 APPLICATOR in 1 JAR (72162-1443-6) / .8 mL in 1 APPLICATOR | December 24, 2024 |
| 45802-962-72 | 45802-962 | Padagis Israel Pharmaceuticals Ltd | 60 APPLICATOR in 1 JAR (45802-962-72) / .8 mL in 1 APPLICATOR | July 7, 2008 |
| 63629-8648 | 63629-8648 | Bryant Ranch Prepack | — | July 7, 2008 |
| 72162-1443 | 72162-1443 | Bryant Ranch Prepack | — | July 7, 2008 |
| 45802-962 | 45802-962 | Padagis Israel Pharmaceuticals Ltd | — | July 7, 2008 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 11 sections on this page.