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Drug Catalog - Product Detail

ERYTHROMYCIN/BENZOYL PEROXIDE TOPICAL GEL 3/5% 46.6GM

NDC Mfr Size Str Form
64980-0328-02 RISING PHARMACEUTICALS 46 5-3% NA
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PACKAGE FILES

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Generic Name
ERYTHROMYCIN AND BENZOYL PEROXIDE
Substance Name
BENZOYL PEROXIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA065385
Description
DESCRIPTION Erythromycin and Benzoyl Peroxide Topical Gel USP contains erythromycin [(3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-Dideoxy-3- C -methyl-3- 0 -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 (C 37 H 67 NO 13 ). 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 and Benzoyl Peroxide Topical Gel USP also contains benzoyl peroxide for topical use. Benzoyl peroxide is an antibacterial and keratolytic agent. Chemically, benzoyl peroxide is (C 14 H 10 O 4 ). 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 and Benzoyl Peroxide Topical Gel USP contains, as dispensed, 30 mg (3%) of erythromycin and 50 mg (5%) of benzoyl peroxide in a base of purified water USP, carbomer 940 NF, ethyl alcohol 20%, sodium hydroxide NF, docusate sodium and fragrance. LABEL LABEL 2
How Supplied
How Supplied and Compounding Directions Size (Net weight) NDC Benzoyl Peroxide Gel Active Erythromycin Powder (In Plastic Vial) 70% Ethyl Alcohol To Be Added 23.3 grams (as dispensed) 64980-328-01 20 grams 0.8 grams 3 mL 46.6 grams (as dispensed) 64980-328-02 40 grams 1.6 grams 6 mL Pharmacist Important - 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 vigorously to completely dissolve erythromycin, then immediately add this solution to gel and stir until homogeneous in appearance (1 to 1-1/2 minutes). Erythromycin and Benzoyl Peroxide Topical Gel USP should then be stored under refrigeration. Do not freeze. Place a 3-month expiration date on the label. Note: Prior to reconstitution, store at room temperature between 15˚ and 30˚C (59˚-86˚F). After reconstitution , store under refrigeration between 2˚ and 8˚C (36˚-46˚F). Do not freeze. Keep tightly closed. Keep out of the reach of children. Rx only Manufactured by: Lyne Laboratories, Inc., Brockton, MA 02301 Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816 R3-05/24
Indications & Usage
INDICATIONS AND USAGE Erythromycin and Benzoyl Peroxide Topical Gel USP is indicated for the topical treatment of acne vulgaris.
Dosage and Administration
DOSAGE AND ADMINISTRATION Erythromycin and Benzoyl Peroxide Topical Gel USP should be applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is thoroughly washed, rinsed with warm water and gently patted dry. How Supplied and Compounding Directions Size (Net weight) NDC Benzoyl Peroxide Gel Active Erythromycin Powder (In Plastic Vial) 70% Ethyl Alcohol To Be Added 23.3 grams (as dispensed) 64980-328-01 20 grams 0.8 grams 3 mL 46.6 grams (as dispensed) 64980-328-02 40 grams 1.6 grams 6 mL Pharmacist Important - 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 vigorously to completely dissolve erythromycin, then immediately add this solution to gel and stir until homogeneous in appearance (1 to 1-1/2 minutes). Erythromycin and Benzoyl Peroxide Topical Gel USP should then be stored under refrigeration. Do not freeze. Place a 3-month expiration date on the label. Note: Prior to reconstitution, store at room temperature between 15˚ and 30˚C (59˚-86˚F). After reconstitution , store under refrigeration between 2˚ and 8˚C (36˚-46˚F). Do not freeze. Keep tightly closed. Keep out of the reach of children. Rx only Manufactured by: Lyne Laboratories, Inc., Brockton, MA 02301 Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816 R3-05/24