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Nighttime control - Medication Information

Product NDC Code 76458-333
Drug Name

Nighttime control

Type Brand
Active Ingredients
Benzoyl peroxide 50 mg/ml
Route TOPICAL
Dosage Form LOTION
RxCUI drug identifier 106309
Application Number M006
Labeler Name Circadia by Dr Pugliese, Inc.
Packages
Package NDC Code Description
76458-333-02 1 bottle in 1 carton (76458-333-02) / 59 ml in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Benzoyl Peroxide 5%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses for the treatment of acne

Purpose

Information about the drug product’s indications for use.
Purpose Acne Treatment

Spl product data elements

Usually a list of ingredients in a drug product.
Nighttime Control Benzoyl Peroxide CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) BENZOYL PEROXIDE BENZOYL PEROXIDE 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

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
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 Label

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Other Information Keep tightly closed Keep away from heat

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep Out of Reach of Children In case of accidental ingestion, get medical help or contact a Poison Control Center Immediately.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? Call toll-free (800) 630-4710

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if irritation becomes severe. ask a doctor before using. If pregnant or breastfeeding,

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API