FDA Label for Nighttime Control

View Indications, Usage & Precautions

Nighttime Control Product Label

The following document was submitted to the FDA by the labeler of this product Circadia By Dr Pugliese, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


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