NDC 70512-035 Erythromycin Gel

Erythromycin Gel

NDC Product Code 70512-035

NDC Product Information

Erythromycin Gel with NDC 70512-035 is a a human prescription drug product labeled by Kbs Solutions. The generic name of Erythromycin Gel is erythromycin gel. The product's dosage form is gel and is administered via topical form.

Labeler Name: Kbs Solutions

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

Product Type: Human Prescription Drug Additional informationCallout TooltipWhat kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Erythromycin Gel Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ERYTHROMYCIN 20 mg/g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ALCOHOL (UNII: 3K9958V90M)
  • HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Pharmacological Class(es)

Additional informationCallout TooltipWhat is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Decreased Sebaceous Gland Activity - [PE] (Physiologic Effect)
  • Macrolide - [EPC] (Established Pharmacologic Class)
  • Macrolide Antimicrobial - [EPC] (Established Pharmacologic Class)
  • Macrolides - [CS]

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Kbs Solutions
Labeler Code: 70512
FDA Application Number: ANDA208154 Additional informationCallout TooltipWhat is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. Additional informationCallout TooltipWhat is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-04-2019 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 Additional informationCallout TooltipWhat is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N Additional informationCallout TooltipWhat is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Erythromycin Gel Product Label Images

Erythromycin Gel Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Erythromycin Topical Gel USP, 2% contains erythromycin (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*,

13S*, 14R*)-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), for topical dermatological use. Erythromycin is a

macrolide antibiotic produced from a strain of Saccharopolyspora erythraea (formerly Streptomyces

erythreus). It is a base and readily forms salts with acids.

Chemically, erythromycin is C H NO . It has the following structural formula:
Erythromycin has a molecular weight of 733.94. It is a white or slightly yellow, odorless or practically

odorless, bitter crystalline powder. Erythromycin is very soluble in very polar organic solvents such as

alcohols, acetone, chloroform, acetonitrile and ethyl acetate. It is moderately soluble in less polar

solvents such as ether, dichloroethylene and amyl acetate. It is slightly soluble in nonpolar solvents

such as hexane. It is very poorly soluble in water.

Each gram of Erythromycin Topical Gel USP, 2% (clear, colorless, gel) contains 20 mg of

erythromycin USP in a vehicle consisting of alcohol (92% v/v) and hydroxypropyl cellulose.

Clinical Pharmacology

The exact mechanism by which erythromycin reduces lesions of acne vulgaris is not fully known;

however, the effect appears to be due in part to the antibacterial activity of the drug.

Microbiology

Erythromycin acts by inhibition of protein synthesis in susceptible organisms by reversibly binding to

50S ribosomal subunits, thereby inhibiting translocation of aminoacyl transfer-RNA and inhibiting

polypeptide synthesis. Antagonism has been demonstrated in vitro between erythromycin, lincomycin,

chloramphenicol, and clindamycin.

Indication And Usage

Erythromycin Topical Gel USP, 2% is indicated for the topical treatment of acne vulgaris.

Contraindications

Erythromycin Topical Gel USP, 2% is contraindicated in those individuals who have shown

hypersensitivity to any of its components.

Warnings

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including

erythromycin, and may range in s everity from mild to life-threatening. Therefore, it is important

to consider this diagnosis in patients who pres ent with diarrhea subs equent 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.

Precautions

General -
For topical use only; not for ophthalmic use. Concomitant topical acne therapy should be used with

caution because a possible cumulative irritancy effect may occur, especially with the use of peeling,

desquamating or abrasive agents.

The use of antibiotic agents may be associated with the overgrowth of antibiotic-resistant organisms. If

this occurs, discontinue use and take appropriate measures.

Avoid contact with eyes and all mucous membranes.
Information for Patients
Patients using Erythromycin Topical Gel USP, 2% should receive the following information and

instructions:

1.This medication is to be used as directed by the physician. It is for external use only. Avoid

contact with the eyes, nose, mouth, and all mucous membranes.

2.This medication should not be used for any disorder other than that for which it was prescribed.

3.Patients should not use any other topical acne medication unless otherwise directed by their

physician.

4.Patients should report to their physician any signs of local adverse reactions.
Carcinogenesis, Mutagenesis, Impairment of Fertility -
No animal studies have been performed to evaluate carcinogenic and mutagenic potential, or effects on

fertility of topical erythromycin. However, long-term (2-year) oral studies in rats with erythromycin

ethylsuccinate and erythromycin base did not provide evidence of tumorigenicity. There was no

apparent effect on male or female fertility in rats fed erythromycin (base) at levels up to 0.25% of diet.
Pregnancy:
Teratogenic Effects:
Pregnancy Category B -
There was no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed

erythromycin base (up to 0.25% of diet) prior to and during mating, during gestation and through

weaning of two successive litters. 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 in pregnancy only if clearly needed. Erythromycin has been reported to cross the

placental barrier in humans, but fetal plasma levels are generally low.
Nursing Women -
It is not known whether erythromycin is excreted in human milk after topical application. However,

erythromycin is excreted in human milk following oral and parenteral erythromycin administration.

Therefore, caution should be exercised when erythromycin is administered to a nursing woman.
Pediatric Use -
Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions

In controlled clinical trials, the incidence of burning associated with erythromycin topical gel USP, 2%

was approximately 25%. The following additional 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 the topical use of erythromycin. A generalized urticarial reaction,

possibly related to the use of erythromycin, which required systemic steroid therapy has been reported.

To report SUSPECTED ADVERSE REACTIONS, contact Teligent Pharma, Inc., at 1-856-697-1441

and/or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Dosage And Administration

Erythromycin Topical Gel USP, 2% should be applied sparingly as a thin film to affected area(s) once

or twice a day after the skin is thoroughly cleansed and patted dry. If there has been no improvement

after 6 to 8 weeks, or if the condition becomes worse, treatment should be discontinued, and the

physician should be reconsulted. Spread the medication lightly rather than rubbing it in. There are no

data directly comparing the safety and efficacy of b.i.d. versus q.d.dosing.
KEEP OUT OF REACH OF CHILDREN

How Supplied

Erythromycin Topical Gel USP, 2% is available as follows:

30 g sealed metal tube (NDC 52565-033-30)

60 g sealed metal tube (NDC 52565-033-60)

STORAGE

Note - FLAMMABLE. Keep away from heat and flame. Store and dispense in original container.

Keep tube tightly closed. Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

Manufactured by:

Teligent Pharma, Inc.

Buena, New Jersey 08310

Rev. 10/2017

Package Label

PRINCIPAL DISPLAY PANEL - 60 g Tube Carton
NDC 52565-033-60

Erythromycin Topical Gel USP, 2%

For Topical Use Only.

Not For Ophthalmic Use.

Net Wt. 60g
Rx Only

* Please review the disclaimer below.

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