Label: ERYTHROMYCIN AND BENZOYL PEROXIDE kit
-
NDC Code(s):
68682-900-23,
68682-901-46,
68682-922-46,
68682-923-23, view more68682-924-08, 68682-925-16
- Packager: Oceanside Pharmaceuticals
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated June 3, 2019
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
DESCRIPTION
Erythromycin-Benzoyl Peroxide Topical Gel 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]. 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 733.94. It is a white crystalline powder and has a solubility of approximately 1 mg/mL in water and is soluble in alcohol at 25°C. Erythromycin-Benzoyl Peroxide Topical Gel also contains benzoyl peroxide for topical use. Benzoyl peroxide is an antibacterial and keratolytic agent.
Chemically benzoyl peroxide is C14H10O4. It has the following structural formula:
Benzoyl peroxide has the molecular weight of 242.23. It is a white granular powder and is sparingly soluble in water and alcohol and soluble in acetone, chloroform and ether.
Each gram of Erythromycin-Benzoyl Peroxide Topical Gel contains, as dispensed, 30 mg (3%) of erythromycin and 50 mg (5%) of benzoyl peroxide in a base of purified water USP, Carbomer Homopolymer Type C, alcohol 20%, sodium hydroxide NF, docusate sodium and fragrance.
-
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.
Benzoyl peroxide has a keratolytic and desquamative effect which may also contribute to its efficacy. Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid.
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. Benzoyl peroxide is an antibacterial agent which has been shown to be effective against Propionibacterium acnes, an anaerobe found in sebaceous follicles and comedones. The antibacterial action of benzoyl peroxide is believed to be due to the release of active oxygen.
- INDICATIONS AND USAGE
- CONTRAINDICATIONS
-
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. If severe irritation develops, discontinue use and institute appropriate therapy.
The use of antibiotic agents may be associated with the overgrowth of nonsusceptible organisms including fungi. If this occurs, discontinue use and take appropriate measures.
Avoid contact with eyes and all mucous membranes.
Information for Patients:
Patients using Erythromycin-Benzoyl Peroxide Topical Gel 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 preparation unless otherwise directed by their physician.
- 4.
- Patients should report to their physician any signs of local adverse reactions.
- 5.
- Erythromycin-Benzoyl Peroxide Topical Gel may bleach hair or colored fabric.
- 6.
- Keep product refrigerated and discard after 3 months.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
Data from a study using mice known to be highly susceptible to cancer suggests that benzoyl peroxide acts as a tumor promoter. The clinical significance of this is unknown.
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
Animal reproduction studies have not been conducted with Erythromycin-Benzoyl Peroxide Topical Gel or benzoyl peroxide.
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 no well-controlled trials in pregnant women with Erythromycin-Benzoyl Peroxide Topical Gel. It also is not known whether Erythromycin-Benzoyl Peroxide Topical Gel can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Erythromycin-Benzoyl Peroxide Topical Gel should be given to a pregnant woman only if clearly needed.
Nursing Women:
It is not known whether Erythromycin-Benzoyl Peroxide Topical Gel 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.
-
ADVERSE REACTIONS
In controlled clinical trials, the incidence of adverse reactions associated with the use of Erythromycin-Benzoyl Peroxide Topical Gel was approximately 3%. These were dryness and urticarial reaction.
The following additional local adverse reactions have been reported occasionally: irritation of the skin including peeling, itching, burning sensation, erythema, inflammation of the face, eyes and nose, and irritation of the eyes. Skin discoloration, oiliness and tenderness of the skin have also been reported.
To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- DOSAGE AND ADMINISTRATION
-
HOW SUPPLIED
How Supplied and Compounding Directions:
Size
(Net Weight)NDC 68682- Benzoyl Peroxide Gel Active Erythromycin Powder (In Plastic Vial) 70% Ethyl Alcohol To Be Added 23.3 grams
(as dispensed)900-23
20 grams
0.8 grams
3 mL
46.6 grams
(as dispensed)901-46
40 grams
1.6 grams
6 mL
Prior to dispensing, tap vial until all powder flows freely. Add indicated amount of room temperature 70% ethyl alcohol to vial (to the mark) and immediately shake to completely dissolve erythromycin. Add this solution to gel and stir until homogeneous in appearance (1 to 1½ minutes). Erythromycin-Benzoyl Peroxide Topical Gel should then be stored under refrigeration. Do not freeze. Place a 3-month expiration date on the label.
-
SPL UNCLASSIFIED SECTION
Distributed by:
Oceanside Pharmaceuticals, a division of
Bausch Health US, LLC
Bridgewater, NJ 08807 USAManufactured by:
Bausch Health Companies Inc.
Laval, Quebec H7L 4A8, Canada© 2019 Bausch Health Companies Inc. or its affiliates
PLEASE READ COMPLETE
COMPOUNDING DIRECTIONSNOTE: TAP VIAL UNTIL ALL POWDER FLOWS FREELY. ADD ROOM TEMPERATURE 70% ETHYL ALCOHOL TO VIAL (TO THE MARK) AND IMMEDIATELY SHAKE/DISSOLVE COMPLETELY.
Rev. 06/19
9437503 - PRINCIPAL DISPLAY PANEL - 46.6 gram Carton
- PRINCIPAL DISPLAY PANEL - 23.3 gram Carton
- PRINCIPAL DISPLAY PANEL -
- Package/Label Display Panel
- Package/Label Display Panel
- Package/Label Display Panel
-
INGREDIENTS AND APPEARANCE
ERYTHROMYCIN AND BENZOYL PEROXIDE
erythromycin and benzoyl peroxide kitProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68682-900 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68682-900-23 1 in 1 CARTON; Type 0: Not a Combination Product 10/26/1984 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL, PLASTIC 0.8 g Part 2 1 JAR 20 g Part 1 of 2 ERYTHROMYCIN
erythromycin gelProduct Information Item Code (Source) NDC:68682-924 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ERYTHROMYCIN (UNII: 63937KV33D) (ERYTHROMYCIN - UNII:63937KV33D) ERYTHROMYCIN 30 mg in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68682-924-08 0.8 g in 1 VIAL, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA050557 10/26/1984 Part 2 of 2 BENZOYL PEROXIDE
benzoyl peroxide gelProduct Information Item Code (Source) NDC:68682-923 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) SODIUM HYDROXIDE (UNII: 55X04QC32I) DOCUSATE SODIUM (UNII: F05Q2T2JA0) WATER (UNII: 059QF0KO0R) LIMONENE, (+)- (UNII: GFD7C86Q1W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68682-923-23 20 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA050557 10/26/1984 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA050557 10/26/1984 ERYTHROMYCIN AND BENZOYL PEROXIDE
erythromycin and benzoyl peroxide kitProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68682-901 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68682-901-46 1 in 1 CARTON; Type 0: Not a Combination Product 10/26/1984 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL, PLASTIC 1.6 g Part 2 1 JAR 40 g Part 1 of 2 ERYTHROMYCIN
erythromycin gelProduct Information Item Code (Source) NDC:68682-925 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ERYTHROMYCIN (UNII: 63937KV33D) (ERYTHROMYCIN - UNII:63937KV33D) ERYTHROMYCIN 30 mg in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68682-925-16 1.6 g in 1 VIAL, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA050557 10/26/1984 Part 2 of 2 BENZOYL PEROXIDE
benzoyl peroxide gelProduct Information Item Code (Source) NDC:68682-922 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) SODIUM HYDROXIDE (UNII: 55X04QC32I) DOCUSATE SODIUM (UNII: F05Q2T2JA0) WATER (UNII: 059QF0KO0R) LIMONENE, (+)- (UNII: GFD7C86Q1W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68682-922-46 40 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA050557 10/26/1984 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA050557 10/26/1984 Labeler - Oceanside Pharmaceuticals (832011691) Establishment Name Address ID/FEI Business Operations Bausch Health Companies Inc 245141858 MANUFACTURE(68682-900, 68682-924, 68682-923, 68682-901, 68682-925, 68682-922) , LABEL(68682-900, 68682-924, 68682-923, 68682-901, 68682-925, 68682-922) , PACK(68682-900, 68682-924, 68682-923, 68682-901, 68682-925, 68682-922)
