Clindamycin Phosphate (Page 2 of 2)

OVERDOSAGE

Topically applied clindamycin phosphate can be absorbed in sufficient amounts to produce systemic effects (see WARNINGS).

DOSAGE AND ADMINISTRATION

Topically applied clindamycin phosphate can be absorbed in sufficient amounts to produce systemic effects (see WARNINGS).

Apply a thin film of Clindamycin Phosphate Topical Solution twice daily to affected area.

Keep all liquid dosage forms in containers tightly closed.

HOW SUPPLIED

Product: 50090-6593

NDC: 50090-6593-0 60 mL in a BOTTLE, WITH APPLICATOR / 1 in a CARTON

Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761

Dist. by: Taro Pharmaceuticals U.S.A., Inc. , Hawthorne, NY 10532

Revised: March, 2021
5201445-0321-9
386

CLINDAMYCIN PHOSPHATE

Label Image

CLINDAMYCIN PHOSPHATE clindamycin phosphate solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-6593(NDC:51672-4081) Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLINDAMYCIN PHOSPHATE (CLINDAMYCIN) CLINDAMYCIN 10 mg in 1 mL

Inactive Ingredients Ingredient Name Strength isopropyl alcohol propylene glycol water

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50090-6593-0 1 BOTTLE, WITH APPLICATOR in 1 CARTON contains a BOTTLE, WITH APPLICATOR 1 60 mL in 1 BOTTLE, WITH APPLICATOR This package is contained within the CARTON (50090-6593-0)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065184 03/31/2004

Labeler — A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Operations
A-S Medication Solutions		830016429	RELABEL (50090-6593)

Revised: 08/2023 A-S Medication Solutions