FDA.reportPublic FDA data

AB Skincare Acne Spot Treatment

Manufacturer
Norris Ltd
Effective date
2018-09-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:56:54

Label at a glance#

ProductAB Skincare Acne Spot Treatment
Active ingredientBENZOYL PEROXIDE
Label structure10 sections

Label contents#

Full prescribing information#

WARNINGS SECTION

For external use ONLY. Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. Avoid unnessary sun exposure and use a sunscreen. Avoid contact with eyes, lips and mouth. Avoid contact with hair, 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 lower concentration.

DO NOT USE If you have very sensitive skin or are sensitive to Benzoyl Peroxide. STOP USE AND ASK DOCTOR if irritation becomes severe.

INSTRUCTIONS FOR USE SECTION

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

GERIATRIC USE SECTION

Keep tightly closed and protect product from freezing or becoming excessively hot. Please refer any questions to 503.887.7087 or www.abskincare.com

DOSAGE & ADMINISTRATION SECTION

One application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness occurs, reduce daily aplication to once a day or every other day.

INACTIVE INGREDIENT SECTION

Water, carbomer, Sodium Dioctyl Sulfosuccinate, Tetrasodium Glutamate Diacetate, Propylene Glycol, Sodium Citrate, Dimethicone, PEG_40, Silica, Sorbitan Stearate, Xanthan Gum

INDICATIONS & USAGE SECTION

If irritation or sensitivy develops stop use of both products and ask a doctor

OTC - PURPOSE SECTION

For the treatment of acne

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.

OTC - ACTIVE INGREDIENT SECTION

Benzoyll Peroxide 10%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TUBE LABELTUBE LABELCARTON LABELCARTON LABEL

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130863724000400GTIN-13: 0863724000400
EAN-13: 0863724000400
GTIN-12: 863724000400
UPC-A: 863724000400
GTIN storage (14 digits): 00863724000400		JULY 13- SPOT TREATMENT CARTON LABEL .jpg

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71563-0400-12020-01-31C16284748780-19d75b9d0-bb99-f424-e053-dadaa90a57ce5437ccae-587a-6be4-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71563-0400-1AB Skincare Acne Spot Treatment28 g in 1 TUBECREAM282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71563-0400AB SKINCARE ACNE SPOT TREATMENT (BENZOYL PEROXIDE) CREAM [NORRIS LTD]2Legacy NDC, 1 package rows20180927_5437ccae-587a-6be4-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71563-040071563-0400-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOYL PEROXIDEW9WZN9A0GMACTIB
METHOXY PEG-406AXS45P1QUIACT
XANTHAN GUMTTV12P4NEEIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
WATER059QF0KO0RIACT
DIMETHICONE 1000MCU2324216IACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
SODIUM CITRATE1Q73Q2JULRIACT
DOCUSATE SODIUMF05Q2T2JA0IACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
2-PHENYLPROPANAL PROPYLENE GLYCOL ACETAL1ZRR9A405AIACT

Source Document#

Source XML

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
76df73c6-0daf-fc83-e053-2991aa0a2b0e5437ccae-587a-6be4-e054-00144ff88e882018-09-27WarningsExact identifier
spl id: 76df73c6-0daf-fc83-e053-2991aa0a2b0e
spl set id: 5437ccae-587a-6be4-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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