Nighttime Control

Dosage form: lotion
Ingredients: BENZOYL PEROXIDE 0.05mL in 1mL
Labeler: Circadia by Dr Pugliese, Inc.
NDC Code: 76458-333

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Nighttime Control

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 persists.

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

Carton Label

NIGHTTIME CONTROL 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76458-333
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE0.05 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
HEXYLDECANOL 
METHYLPROPANEDIOL 
CETOSTEARYL ALCOHOL 
GLYCERYL 1-STEARATE 
PEG-100 STEARATE 
CETEARYL GLUCOSIDE 
DIMETHICONE 
.ALPHA.-TOCOPHEROL ACETATE 
ALLANTOIN 
CAPRYLYL GLYCOL 
HEXYLENE GLYCOL 
METHYLISOTHIAZOLINONE 
SODIUM HYDROXIDE 
POLYOXYL 20 CETOSTEARYL ETHER 
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) 
Packaging
#Item CodePackage Description
1NDC:76458-333-021 BOTTLE in 1 CARTON
159 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333D07/15/2012
Labeler - Circadia by Dr Pugliese, Inc. (013694423)

Revised: 08/2012
 
Circadia by Dr Pugliese, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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