FDA.reportPublic FDA data

KATE SOMERVILLE (as PLD) - ANTI BAC ACNE CLEARING LOTION (43479-105)

Manufacturer
KATE SOMERVILLE SKINCARE, LLC
Effective date
2025-01-12
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-01 20:42:57

Label at a glance#

ProductANTI BAC ACNE CLEARING
Active ingredientBENZOYL PEROXIDE
Label structure11 sections

Dosage and administration

CLEANSE SKIN THOROUGHLY BEFORE APPLYING. COVER THE AFFECTED AREA WITH A THIN LAYER 1 TO 3 TIMES A DAY. 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. IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCT APPLICATION TO ONCE A DAY OR EVERY OTHER DAY. IF GOING OUTSIDE, APPLY SUNSCREEN AFTER USING THIS PRODU...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

BENZOYL PEROXIDE- 5%

PURPOSE

OTC - PURPOSE SECTION

ACNE TREATMENT

USE

INDICATIONS & USAGE SECTION

  • FOR THE TREATMENT OF ACNE
  • HELPS KEEP SKIN CLEAR OF NEW ACNE BLEMISHES

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY

OTC - WHEN USING SECTION

WHEN USING THIS PRODUCT

  • USING OTHER TOPICAL  ACNE MEDICATION AT THE SAME TIME OR IMMEDIATELY FOLLOWING THE 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 UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN.
  • AVOID CONTACT WITH EYES, LIPS, AND MOUTH.
  • AVOID CONTACT WITH HAIR AND DYED FABRICS, WHICH MAY BE BLEACHED BY THIS PRODUCT.
  • SKIN IRRITATION MY OCCUR, CHARACTERIZED BY REDNESS, BURNING, ITCHING, PEELING, OR POSSIBLE SWELLING. IRRITATION MY BE REDUCED BY USING THE PRODUCT LESS FREQUENTLY OR IN A LOWER CONCENTRATION.

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF SKIN IRRITATION BECOMES SEVERE.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • CLEANSE SKIN THOROUGHLY BEFORE APPLYING. COVER THE AFFECTED AREA WITH A THIN LAYER 1 TO 3 TIMES A DAY. 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. IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCT 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.

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • YOU MAY REPORT A SERIOUS ADVERSE REACTION FROM USING THIS PRODUCT TO 1-800-984-KATE ON WEEKDAYS 9 A.M.-5 P.M. PT

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER/AQUA/EAU, PPG-2 MYRISTYL ETHER PROPIONATE, ARGANIA SPINOSA KERNEL EXTRACT, PEG-40 STEARATE, 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, PALMITIC ACID, SODIUM ASCORBATE, SODIUM HYDROXIDE, EDTA, ETHYLHEXYLGLYCERIN, PHENOXYETHANOL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0-UC_Anti-Bac_50mL0-UC_Anti-Bac_50mL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43479-105ANTI BAC ACNE CLEARING (BENZOYL PEROXIDE) LOTION [KATE SOMERVILLE SKINCARE, LLC]10Legacy NDC20250113_73f84827-2803-4335-b6d4-8a861ca87f12.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GM4
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GM4
ALCOHOLINACTIVE INGREDIENT3K9958V90M4
ARGANIA SPINOSA SEEDINACTIVE INGREDIENT8H7X7XB54H4
CARBOMER 940INACTIVE INGREDIENT4Q93RCW27E4
CERAMIDE 2INACTIVE INGREDIENTC04977SRJ54
CERAMIDE 3INACTIVE INGREDIENT4370DF050B4
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN4
CHOLESTEROLINACTIVE INGREDIENT97C5T2UQ7J4
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LU4
EDETIC ACIDINACTIVE INGREDIENT9G34HU7RV04
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 600000 MW)INACTIVE INGREDIENTXRK36F13ZZ4
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE44
HYDROGENATED METHYL ABIETATEINACTIVE INGREDIENTA23O709X8O4
HYDROGENATED SOYBEAN LECITHININACTIVE INGREDIENTH1109Z9J4N4
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CP4
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H14
PEG-40 STEARATEINACTIVE INGREDIENTECU18C66Q74
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T4
PPG-2 MYRISTYL ETHER PROPIONATEINACTIVE INGREDIENT88R97D8U8A4
SAW PALMETTOINACTIVE INGREDIENTJ7WWH9M8QS4
SESAME SEEDINACTIVE INGREDIENT7Y1255HVXR4
SODIUM ASCORBATEINACTIVE INGREDIENTS033EH83594
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I4
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58X4
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43479-10543479-105-12, 43479-105-52

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PPG-2 MYRISTYL ETHER PROPIONATE88R97D8U8AIACT
ARGANIA SPINOSA SEED8H7X7XB54HIACT
PEG-40 STEARATEECU18C66Q7IACT
SAW PALMETTOJ7WWH9M8QSIACT
SESAME SEED7Y1255HVXRIACT
ALCOHOL3K9958V90MIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
HYDROGENATED METHYL ABIETATEA23O709X8OIACT
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 600000 MW)XRK36F13ZZIACT
CARBOMER 9404Q93RCW27EIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETYL ALCOHOL936JST6JCNIACT
EDETATE SODIUMMP1J8420LUIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
CHOLESTEROL97C5T2UQ7JIACT
CERAMIDE 2C04977SRJ5IACT
CERAMIDE 34370DF050BIACT
OLEIC ACID2UMI9U37CPIACT
PALMITIC ACID2V16EO95H1IACT
SODIUM ASCORBATES033EH8359IACT
SODIUM HYDROXIDE55X04QC32IIACT
EDETIC ACID9G34HU7RV0IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB

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 6 · 360 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii candidate
174 equally ranked IID candidates
OLEIC ACIDOLEIC ACID2UMI9U37CPAEROSOL, METERED / RESPIRATORY (INHALATION)0.01 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL23 mgExact identifier — unii candidate
21 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii candidate
20 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSHAMPOO / TOPICAL1.33 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAVENOUS78 mgExact identifier — unii candidate
174 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRACARDIACADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INFILTRATIONADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
OLEIC ACIDOLEIC ACID2UMI9U37CPSOLUTION / TOPICAL7.4 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL, METERED / TRANSDERMAL350 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, DELAYED RELEASE / ORAL4 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / SUBCUTANEOUS31.45 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, EXTENDED RELEASE / ORAL13 mgExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4OINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IENEMA / RECTAL0.44 %v/vExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM ASCORBATESODIUM ASCORBATES033EH8359INJECTION / INTRAVENOUS625 mgExact identifier — unii candidate
7 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISPONGE / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAOCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
OLEIC ACIDOLEIC ACID2UMI9U37CPCAPSULE / ORAL8759 mgExact identifier — unii candidate
11 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0TABLET, FILM COATED / ORAL0.2 mgExact identifier — unii candidate
13 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCAPSULE, DELAYED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0INJECTION, SOLUTION / SUBMUCOSAL0.03 %w/vExact identifier — unii candidate
13 equally ranked IID candidates
HYDROGENATED SOYBEAN LECITHINHYDROGENATED SOYBEAN LECITHINH1109Z9J4NSUSPENSION / AURICULAR (OTIC)0.15 %w/vExact identifier — unii candidate
4 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XCREAM / VAGINAL100 mgExact identifier — unii candidate
11 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, FILM COATED / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVASCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUTABLET / ORAL5 mgExact identifier — unii candidate
12 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IPOWDER / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii candidate
174 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0SUPPOSITORY / RECTAL7 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET / ORAL33.34 mgExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOLUTION / TOPICAL0.3 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE, LIQUID FILLED / ORAL1.5 mgExact identifier — unii candidate
174 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / NASAL20 mgExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSPONGE / TOPICAL0.14 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / EPIDURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRADERMALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, EXTENDED RELEASE / ORAL32.4 mgExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IJELLY / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRADERMALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRALESIONALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM ASCORBATESODIUM ASCORBATES033EH8359INJECTION, POWDER, FOR SOLUTION / INTRADERMAL0.5 mgExact identifier — unii candidate
7 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
44ebe505-1ce6-88cf-e063-6394a90a4baf73f84827-2803-4335-b6d4-8a861ca87f122025-12-01WarningsExact identifier
spl set id: 73f84827-2803-4335-b6d4-8a861ca87f12

Reported adverse events (FAERS/openFDA)#

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