Nighttime Control

Nighttime Control
SPL v5
SPL
SPL Set ID fb4cc832-4cfd-4e29-a78e-ab848681a224
Route
TOPICAL
Published
Effective Date 2020-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (50 mg)
Inactive Ingredients
Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) 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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-07-15

Description

Benzoyl Peroxide 5%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Benzoyl Peroxide 5%

Uses

for the treatment of acne

Warnings

For external use only

Do not use if you

When using this product

  • have very sensitive skin
  • are sensitive to benzoyl peroxide
  • 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.
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.
  • Follow directions on sunscreen labeling. If sensitivity develops, discontinue use of both products and consult a doctor. If going outside apply a sunscreen after using this product.

Questions?

Call toll-free (800) 630-4710

Active Ingredient

Benzoyl Peroxide 5%

Other Information
  • Keep tightly closed
  • Keep away from heat
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

Stop Use and Ask A Doctor

if irritation becomes severe.

ask a doctor before using. If pregnant or breastfeeding,

Keep Out of Reach of Children

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

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




Structured Label Content

Uses

for the treatment of acne

Purpose

Acne Treatment

Warnings

For external use only

Do not use if you

When using this product

  • have very sensitive skin
  • are sensitive to benzoyl peroxide
  • 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.
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.
  • Follow directions on sunscreen labeling. If sensitivity develops, discontinue use of both products and consult a doctor. If going outside apply a sunscreen after using this product.

Questions?

Call toll-free (800) 630-4710

Active Ingredient (Active ingredient)

Benzoyl Peroxide 5%

Other Information
  • Keep tightly closed
  • Keep away from heat
Inactive Ingredients (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

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if irritation becomes severe.

ask a doctor before using. If pregnant or breastfeeding,

Keep Out of Reach of Children

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

Package/label Principal Display Panel (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




Advanced Ingredient Data


Raw Label Data

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