Prescription Drug Information: NuCaraClinPAK (Page 2 of 2)

OVERDOSAGE

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

DOSAGE AND ADMINISTRATION

Apply a thin film of Clindamycin Phosphate Topical Solution, Clindamycin Phosphate Lotion, or Clindamycin Phosphate Gel twice daily to affected area.

Lotion: Shake well immediately before using.

Keep all liquid dosage forms in containers tightly closed.

HOW SUPPLIED

Clindamycin Phosphate Gel, USP 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per gram is available in the following sizes:

30 gram tube NDC 0168-0202-30

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Protect from freezing.

Fougera PHARMACEUTICALS INC.

E. FOUGERA & CO.
A division of Fougera Pharmaceuticals Inc.
MELVILLE, NEW YORK 11747

46206122A/46206123A
R03/18

ACTIVE INGREDIENTS

Octinoxate 7.5% ……………..Sunscreen
Octisalate 5% …………………Sunscreen
Octocrylene 7% ………………Sunscreen
Oxybenzone 6% ……………..Sunscreen Titanium Dioxide 5.7% ……..Sunscreen

USES

Helps prevent sunburn.

WARNINGS

Skin Cancer/Skin Aging Alert:

Spending time in the sun increases your risk of skin cancer and early aging. This product has been shown to help prevent sunburn, not skin cancer or early aging.

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Apply liberally 15 minutes before sun exposure. • Use a water resistant sunscreen if swimming or sweating. • Reapply at least every 2 hours. • Children under 6 months: ask a doctor.

INACTIVE INGREDIENTS

Water, Propylene Glycol, Glycerin, Dimethicone, VP/Eicosene Copolymer, Cyclomethicone, Stearic Acid, Dimethiconol, Potassium Cetyl Phosphate, Glyceryl Stearate, PEG-100 Stearate, Aluminum Hydroxide, Disodium EDTA, Tocopherol, Triethanolamine, Phenoxyethanol, Ethylparaben, Chlorphenesin, Cetyl Alcohol, Carbomer, Methylparaben, Xanthan Gum

OTHER INFORMATION

• Protect this product from excessive heat and direct sun.

QUESTIONS

1-866-735-4137

CETAPHIL DAILY FACIAL MOISTURIZER(0299-4930-02)

CLINDAMYCIN PHOSPHATE GEL 30g(0168-0202-30)

pdp
(click image for full-size original)

NDC 0168-0203-60

Fougera ®

CLINDAMYCIN
PHOSPHATE
LOTION
(Clindamycin
Phosphate Topical
Suspension
USP, 1%)

Equivalent to 1%
(10 mg/mL) clindamycin

FOR TOPICAL USE ONLY.

60 mL

Rx only

E. FOUGERA & CO.
A division of
Fougera Pharmaceuticals Inc. Melville, New York 11747

CETAPHIL DAILY FACIAL MOISTURIZER 50mL (0299-4930-02)

PDP
(click image for full-size original)

NuCaraClinPAK (70859-051-01)

PDP
(click image for full-size original)

NUCARACLINPAK clindamycin phosphate,cetaphil kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70859-051
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70859-051-01 1 KIT in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 TUBE 50 mL
Part 2 1 TUBE 30 g
Part 1 of 2
CETAPHIL DAILY FACIAL MOISTURIZER WITH SUNCREEN SPF 50 octinoxate, octisalate, octocrylene, oxybenzone, titanium dioxide lotion
Product Information
Item Code (Source) NDC:0299-4930
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 70 mg in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 60 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg in 1 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 57 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
STEARIC ACID
PHENOXYETHANOL
CHLORPHENESIN
CETYL ALCOHOL
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
METHYLPARABEN
XANTHAN GUM
CYCLOMETHICONE
VINYLPYRROLIDONE/EICOSENE COPOLYMER
DIMETHICONE
GLYCERIN
ALUMINUM HYDROXIDE
GLYCERYL MONOSTEARATE
TOCOPHEROL
WATER
PROPYLENE GLYCOL
POTASSIUM CETYL PHOSPHATE
PEG-100 STEARATE
DIMETHICONOL (40 CST)
EDETATE DISODIUM (EDETIC ACID)
TROLAMINE
ETHYLPARABEN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0299-4930-02 1 TUBE in 1 CARTON contains a TUBE
1 50 mL in 1 TUBE This package is contained within the CARTON (0299-4930-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 01/01/2012
Part 2 of 2
CLINDAMYCIN PHOSPHATE clindamycin phosphate gel
Product Information
Item Code (Source) NDC:0168-0202
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN PHOSPHATE (CLINDAMYCIN) CLINDAMYCIN 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
POLYETHYLENE GLYCOL 400
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
SODIUM HYDROXIDE
METHYLPARABEN
PROPYLENE GLYCOL
ALLANTOIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0168-0202-30 1 TUBE in 1 CARTON contains a TUBE
1 30 g in 1 TUBE This package is contained within the CARTON (0168-0202-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064160 06/28/2000
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064160 01/28/2000
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 manufacture (70859-051)

Revised: 05/2021 NuCare Pharmaceuticals,Inc.

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