Clindamycin Phosphate and Benzoyl Peroxide (Page 5 of 5)

INSTRUCTIONS FOR USE

Clindamycin Phosphate (klin-da-MYE-sin fos-fate) and Benzoyl Peroxide (BEN-zoe-il peer-OKS-ide) Gel, 1.2%/2.5%

Important Information: Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is for use on skin only (topical use). Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is not for use in your mouth, eyes or vagina

Read this Instructions for Use before you start using Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.

Apply Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% to your face 1 time each day as prescribed.
Before you apply Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%, wash your face gently with a mild soap, rinse with warm water, and pat your skin dry.
To apply Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% to your face, use the pump to dispense one pea-sized amount of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% onto your fingertip. See Figure 1.
One pea-sized amount of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% should be enough to cover your entire face.
figure-1
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Figure 1

Dot the one pea-sized amount of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% onto six areas of your face (chin, left cheek, right cheek, nose, left forehead, right forehead). See Figure 2.
figure-2
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Figure 2

Spread the gel over your face and gently rub it in. It is important to spread the gel over your entire face. If your doctor tells you to put Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% on other areas of your skin with acne, be sure to ask how much you should use.
Wash your hands with soap and water after applying Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%.
How should I store Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%?
Store Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% at room temperature at or below 77°F (25°C).
Do not freeze Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%.
Throw away (discard) Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% that has passed the expiration date.
Store pump upright.
Keep the container tightly closed.

Keep Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% and all medicines out of the reach of children.

The Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Made in Israel
Manufactured By Perrigo
Yeruham, Israel

Distributed By Perrigo
Allegan, MI 49010

www.perrigorx.com

Rev 07-20

Package/Label Display Panel- Carton

Rx Only

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%

For Topical Use Only

One premixed 50-gram pump dispenser

label
(click image for full-size original)
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
clindamycin phosphate, benzoyl peroxide gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-597
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 25 mg in 1 g
CLINDAMYCIN PHOSPHATE (CLINDAMYCIN) CLINDAMYCIN 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
PROPYLENE GLYCOL
POTASSIUM HYDROXIDE
Product Characteristics
Color WHITE (White-to-off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45802-597-01 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
1 50 g in 1 BOTTLE, PUMP This package is contained within the CARTON (45802-597-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205397 09/12/2019
Labeler — Perrigo New York Inc (078846912)

Revised: 07/2020 Perrigo New York Inc

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