NIGHTTIME CONTROL- benzoyl peroxide lotion

Nighttime Control by

Drug Labeling and Warnings

Nighttime Control by is a Otc medication manufactured, distributed, or labeled by Circadia by Dr Pugliese, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzoyl Peroxide 5%

Purpose

Acne Treatment

Uses

for the treatment of acne

Warnings

For external use only

Do not use if you

• have very sensitive skin
• are sensitive to benzoyl peroxide

When using this product

• avoid unnecessary sun exposure and use a sunscreen
• avoid contact with the eyes, lips and mouth
• avoid contact with hair and dyed fabrics, which may be bleached by this product
• skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration
• at the same time as other topical acne medications, increased dryness or irritation is more likely to occur. If this occurs, only one medication should be used unless directed by a doctor.

Stop use and ask a doctor

if irritation becomes severe.

If pregnant or breastfeeding, ask a doctor before using.

Keep Out of Reach of Children

In case of accidental ingestion, get medical help or contact a Poison Control Center Immediately.

Directions

• Cleanse skin thoroughly before applying Nighttime Control.
• Cover entire affected area with a thin layer 1 to 3 times daily.
• Because excessive drying of the skin may occur, start with 1 application every day, or every other day, gradually increasing to 2 or 3 times a day if needed or as directed by a doctor.
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
• If going outside apply a sunscreen after using this product.
  Follow directions on sunscreen labeling. If sensitivity develops, discontinue use of both products and consult a doctor.

Inactive ingredients

Water, hexyldecanol, methyl propanediol, cetearyl alcohol, glyceryl stearate, PEG-100 stearate, cetereth-20, cetearyl glucoside, dimethicone, carbomer, tocopheryl acetate, allantoin, sodium hydroxide, caprylyl glycol, hexylene glycol, methylisothiazolinone

Other Information

• Keep tightly closed
• Keep away from heat

Questions?

Call toll-free (800) 630-4710

Package/Label Principal Display Panel

Nighttime Control Benzoyl Peroxide Lotion

Advanced Professional Skincare

2 fl oz (59 ml)

Circadia by Dr. Pugliese, Inc.
8371 Route 183 Bethel, PA 19507
Circadia.com

INGREDIENTS AND APPEARANCE

NIGHTTIME CONTROL 
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76458-333
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 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HEXYLDECANOL (UNII: 151Z7P1317)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
PEG-100 STEARATE (UNII: YD01N1999R)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76458-333-02	1 in 1 CARTON	07/15/2012
1		59 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	07/15/2012

Labeler - Circadia by Dr Pugliese, Inc. (013694423)

Establishment
Name	Address	ID/FEI	Business Operations
PhytogenX, Inc.		624386772	manufacture(76458-333)