FDA.reportPublic FDA data

Anti Bac Clearing Lotion

Manufacturer
Cosmetic Enterprise Ltd
Effective date
2025-10-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:38:50

Label at a glance#

ProductAnti Bac Acne Clearing
Active ingredientBENZOYL PEROXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Benzoyl Peroxide 5%

Purpose

Acne Treatment

OTC - PURPOSE SECTION

Use

  • For the treatment of acne
  • Helps keep skin clear of new acne blemishes

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Stop use and ask a doctorif irritation becomes severe.

WARNINGS SECTION

Warnings

For external use only

  • When using this product
  • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
  • Do not use this product if you have very sensitive skin or if you are sensitive to Benzoyl Peroxide.
  • Avoid unnecesary 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 possible swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Clease Skin thoroughly before applying. Cover the affected area with a thin layer 1 to 3 days. Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • If going outside apply sunscreen after using this product. If irritation or sensitivity develops, stop use of products and ask a doctor.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water/Aqua/Eau, PPG-2 Myristyl Ether Propionate, Argania Spinosa Kernel Extract, PEG-40 Sterate, Serenoa Serrulata Fruit Extract, Sesamum Indicum (sesame) Seed Extract, Alcohol Denat., Sorbitan Stearate, Hydrogenated Methyl Abeitate, Methyl Methacrylate Crosspolymer, Carbomer, Glyceryl Stearate, Cetyl Alcohol, Tetrasodium EDTA, Hydrogenated Lecithin, Cholesterol, Ceramide NS, Ceramide NP, Oleic Acid, Plamitic Acid, Sodium Ascorbate, Sodium Hydroxide, EDTA, Ethylhexylglycerin, Phenoxyethanol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kate Somerville

Acne/Peau acneique

5% Benzoyl Peroxide

Anti Bac

Acne Clearing Lotion

Lotion purifiante actibacterienne

50mL 1.7 Fl Oz Liq

Acne LabelAcne Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1541091Anti Bac 5 % Topical LotionPSN4
106309benzoyl peroxide 5 % Topical LotionPSN4
1541091benzoyl peroxide 50 MG/ML Topical Lotion [Anti Bac]SBD4
106309benzoyl peroxide 50 MG/ML Topical LotionSCD4
1541091Anti Bac 5 % Topical LotionSY4
1541091Anti Bac 50 MG/ML Topical LotionSY4
106309benzoyl peroxide 5 % Topical LotionSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56152-4012-1Anti Bac Acne Clearing50 mL in 1 BOTTLELOTION504

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
56152-401256152-4012-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMEREG97988M5QIACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB
PEG-40 STEARATEECU18C66Q7IACT
WATER059QF0KO0RIACT
PPG-2 MYRISTYL ETHER PROPIONATE88R97D8U8AIACT
SERENOA REPENS WHOLE487DXM62F2IACT
SESAME SEED7Y1255HVXRIACT
SODIUM ASCORBATES033EH8359IACT
SODIUM HYDROXIDE55X04QC32IIACT
EDETIC ACID9G34HU7RV0IACT
PHENOXYETHANOLHIE492ZZ3TIACT
EDETATE SODIUMMP1J8420LUIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
HYDROGENATED METHYL ABIETATEA23O709X8OIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETYL ALCOHOL936JST6JCNIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
CHOLESTEROL97C5T2UQ7JIACT
CERAMIDE NS DILAURATE1SL625KAAVIACT
CERAMIDE NP4370DF050BIACT
OLEIC ACID2UMI9U37CPIACT
PALMITIC ACID2V16EO95H1IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-11-04full-release2026-06-01 00:33:57

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
Anti Bac Acne ClearingBENZOYL PEROXIDECosmetic Enterprise Ltd7f6ee76b-c664-2ec4-e053-2991aa0a94882025-10-10WarningsExact identifier
ndc (package): 56152-4012-1
ndc (product): 56152-4012
ndc11 (package): 56152401201
spl id: 40d3a24a-e2c7-26eb-e063-6294a90a2a35
spl set id: 7f6ee76b-c664-2ec4-e053-2991aa0a9488

Reported adverse events (FAERS/openFDA)#

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