FDA.reportPublic FDA data

Nighttime Control

Manufacturer
Circadia by Dr Pugliese, Inc.
Effective date
2023-12-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:04:32

Label at a glance#

ProductNighttime Control
Active ingredientBENZOYL PEROXIDE
Label structure11 sections

Indications and uses

for the treatment of acne

Dosage and administration

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 directi...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 5%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

for the treatment of acne

Warnings

WARNINGS SECTION

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.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation becomes severe.

ask a doctor before using. If pregnant or breastfeeding,

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 ingredients

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

  • Keep tightly closed
  • Keep away from heat

Questions?

OTC - QUESTIONS SECTION

Call toll-free (800) 630-4710

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

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106309benzoyl peroxide 5 % Topical LotionPSN5
106309benzoyl peroxide 50 MG/ML Topical LotionSCD5
106309benzoyl peroxide 5 % Topical LotionSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76458-333-022020-02-29C16284748780-197449f38-c81e-f6ea-e053-dbdaa90aa703Nighttime Control
76458-333-022019-11-13C16284748780-197449f38-c81e-f6ea-e053-dbdaa90aa703Nighttime Control

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76458-333-02Nighttime Control1 in 1 CARTONLOTION15
76458-333-02Nighttime Control59 mL in 1 BOTTLELOTION595

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76458-333NIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.]5Current NDC, Legacy NDC, 2 package rows20231215_fb4cc832-4cfd-4e29-a78e-ab848681a224.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GM1
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GM1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
ALLANTOININACTIVE INGREDIENT344S277G0Z1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5CO1
CETEARYL GLUCOSIDEINACTIVE INGREDIENT09FUA47KNA1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
GLYCERYL 1-STEARATEINACTIVE INGREDIENT258491E1RZ1
HEXYLDECANOLINACTIVE INGREDIENT151Z7P13171
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75J1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFA1
METHYLPROPANEDIOLINACTIVE INGREDIENTN8F53B3R4R1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUY1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76458-33376458-333-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB
WATER059QF0KO0RIACT
HEXYLDECANOL151Z7P1317IACT
METHYLPROPANEDIOLN8F53B3R4RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL 1-STEARATE258491E1RZIACT
PEG-100 STEARATEYD01N1999RIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
DIMETHICONE92RU3N3Y1OIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALLANTOIN344S277G0ZIACT
CAPRYLYL GLYCOL00YIU5438UIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
SODIUM HYDROXIDE55X04QC32IIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 26 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERYL 1-STEARATEGLYCERYL 1-STEARATE258491E1RZOINTMENT / TOPICAL3 %w/wExact identifier — unii+route
2 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHERPOLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYLOTION / TOPICAL71 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JGEL / TOPICAL280 mgExact identifier — unii+route
8 equally ranked IID candidates
ALLANTOINALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route
2 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JGEL / TOPICAL280 mgExact identifier — unii+route
8 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
6 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route
8 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JOINTMENT / TOPICAL12 %w/wExact identifier — unii+route
8 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
6 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
6 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
6 equally ranked IID candidates
ALLANTOINALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route
2 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERYL 1-STEARATEGLYCERYL 1-STEARATE258491E1RZOINTMENT / TOPICAL3 %w/wExact identifier — unii+route
2 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JCREAM / TOPICAL385 mgExact identifier — unii+route
8 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JCREAM / TOPICAL385 mgExact identifier — unii+route
8 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILOTION / TOPICAL21 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
6 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JOINTMENT / TOPICAL12 %w/wExact identifier — unii+route
8 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILOTION / TOPICAL21 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
6 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHERPOLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYLOTION / TOPICAL71 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SLOTION / TOPICAL3627 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route
8 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SLOTION / TOPICAL3627 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime ControlBENZOYL PEROXIDECircadia by Dr Pugliese, Inc.fb4cc832-4cfd-4e29-a78e-ab848681a2242023-12-15WarningsExact identifier
ndc (package): 76458-333-02
ndc (product): 76458-333
ndc11 (package): 76458033302
spl id: 0c86a86e-1d0e-8fa8-e063-6294a90a5963
spl set id: fb4cc832-4cfd-4e29-a78e-ab848681a224

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.