NDC 54868-0946 Erythromycin

NDC Product Code 54868-0946

NDC 54868-0946-0

Package Description: 60 SOLUTION in 1 BOX

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Erythromycin with NDC 54868-0946 is a product labeled by Physicians Total Care, Inc.. The generic name of Erythromycin is . The product's dosage form is and is administered via form.

Labeler Name: Physicians Total Care, Inc.

Dosage Form: -

Product Type: What 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.

Inactive Ingredient(s)

About 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)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Physicians Total Care, Inc.
Labeler Code: 54868
Start Marketing Date: 03-29-1996 What 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: 12-31-2017 What 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: I What 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’.

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Erythromycin Product Label Images

Erythromycin 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

Other

For Dermatologic Use OnlyNot for Ophthalmic
UseRx only

E. FOUGERA & CO.a
division of Altana Inc.MELVILLE, NY 11747IF221501R6/06#46Relabeling of "Additional Barcode Label" by:Physicians Total Care, Inc.Tulsa, OK      74146

Description

Erythromycin Pledgets, USP contains erythromycin ((3R*,4S*,5S*,6R*,7R*,9R*,11R*,12R*,13S*,14R*)-4-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-⌊-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 dermatologic 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
C37H67NO13.
It has the following structural formula: Erythromycin has the molecular weight of 733.94It is a white powder, is freely soluble in alcohols, acetone, chloroform,
acetonitrile, ethyl acetate, and moderately soluble in ether, ethylene
dichloride and amyl acetate. Erythromycin pledgets, USP are absorbent pads
impregnated with Erythromycin Topical Solution 2%. Each pledget contains 1 mL of
Erythromycin Topical Solution 2% and each 1 mL of Erythromycin Topical Solution
2% contains 20 mg of erythromycin base in a vehicle consisting of alcohol (71.5%
v/v) and propylene glycol. May contain anhydrous citric acid and/or alcohol to
adjust pH.

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 50 S 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.

Indications And Usage

Erythromycin pledgets, USP are indicated for the topical treatment of acne
vulgaris.

Contraindications

Erythromycin pledgets, USP are 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
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.

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 pledgets, USP should receive the following information and
  • Instructions: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.This medication should not be used for any disorder other than that for
  • Which it was prescribed.Patients should not use any other topical acne medication unless otherwise
  • Directed by their physician.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 the
  • 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% 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 Ievels are generally low.Nursing Mothers: 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
  • Of this product in pediatric patients have not been established.

Adverse 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.

Dosage And Administration

Erythromycin pledgets, USP should be rubbed over the affected area twice a day
after the skin is thoroughly washed with warm water and soap and patted dry.
Acne lesions on the face, neck, shoulder, chest, and back may be treated in this
manner. Additional pledgets may be used, if needed. Each pledget should be used
once and discarded.

How Supplied

Each pledget is filled to contain 1 mL of Erythromycin Topical
Solution USP 2%. Each mL of Erythromycin Topical Solution USP 2% contains 20 mg
of erythromycin.Each pledget is supplied in an individual foil packet in boxes of 60.NDC 54868-0946-0.Store at 20°- 25°C (68°- 77°F)[See USP Controlled Room
Temperature].

Information For Patients

  • Remove this portion before dispensingERYTHROMYCIN PLEDGETS, USPPatient Information LeafletThis 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.This medication should not be used for any disorder other than that for
  • Which it was prescribed.Patients should not use any other topical acne medication unless otherwise
  • Directed by their physician.Patients should report to their physician any signs of local adverse
  • Reactions.E. FOUGERA & CO.a division of Altana Inc.MELVILLE, NEW YORK
  • 11747

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