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

Purpose

Acne Treatment

Description

Benzoyl Peroxide 5%


Medication Information

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.
Uses

for the treatment of acne

Purpose

Acne Treatment

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.

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

Description

Benzoyl Peroxide 5%

Questions?

Call toll-free (800) 630-4710

Active Ingredient

Benzoyl Peroxide 5%

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

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.
Uses

for the treatment of acne

Purpose

Acne Treatment

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.

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

Questions?

Call toll-free (800) 630-4710

Active Ingredient (Active ingredient)

Benzoyl Peroxide 5%

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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