FDA.reportPublic FDA data

AOSORW Folliculitis and Acne Treatment Cream

Manufacturer
SpineStatus LLC
Effective date
2025-11-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:41:52

Label at a glance#

ProductAOSORW Folliculitis and Acne Treatment Cream
Active ingredientSALICYLIC ACID
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 1%

OTC - PURPOSE SECTION

Acne Treatment

INDICATIONS & USAGE SECTION

  • For the treatment of acne
  • Helps prevent newacne blemishes

WARNINGS SECTION

For external use only

OTC - ASK DOCTOR SECTION

lf you are under 2 years of age.

OTC - WHEN USING SECTION

  • Skin irritation and dryness are morelikely to occur when using another topical acne product at thesame time. lf irritation occurs, use only one product at a time
  • Avoid eye area. In case of eye contact, flush gently and thoroughlywith water

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

lf swallowed, get medical helpor contact the Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

  • Clean the skin thoroughly before applying this product.
  • Cover the entire affected area with a thin layer one to threetimes daily.
  • Because excessive drying of the skin may occur,start with one application daily, then gradually increase to two or three daily if needed or as directed by a doctor.
  • lf bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. lf no discomfort occurs, follow the directions stated elsewhere on this label.

OTHER SAFETY INFORMATION

Store at room temperature and out of direct sunlight. Keep the cap tightly closed after use。

INACTIVE INGREDIENT SECTION

Water, Glycerin, Cetearyl Alcohol, Propylene Glycol,Dimethicone,Sophora Flavescens Extract, Butyrospermum, Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Oldenlandia Diffusa Extract, PEG-100 Stearate, Dextrin, 1,2-HexanediolAloe Barbadensis Leaf Juice, Hydroxyacetophenone, CetearylGlucoside, Glyceryl Stearate, Panthenol, Triethanolamine Polyacrylate Crosspolymer-6, Carbomer, Allantoin, Niacinamide.Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer,Tocopheryl Acetate, Dipotassium Glycyrrhizate, Avena Sativa(Oat)Kernel Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Azelaic Acid, Ceramide NP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagePackage

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
417424salicylic acid 1 % Topical CreamPSN2
417424salicylic acid 10 MG/ML Topical CreamSCD2
417424salicylic acid 1 % Topical CreamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85498-012-01AOSORW Folliculitis and Acne Treatment Cream100 g in 1 JARCREAM1002

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85498-01285498-012-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
AVENA SATIVA (OAT) KERNEL OIL3UVP41R77RIACT
GLYCERINPDC6A3C0OXIACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILVIF565UC2GIACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
CERAMIDE NP4370DF050BIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIETHANOLAMINE9O3K93S3TKIACT
POLYACRYLATE CROSSPOLYMER-6Q7UI015FF9IACT
DEXTRIN, CORNVAD2K35XAJIACT
NIACINAMIDE25X51I8RD4IACT
DIPOTASSIUM GLYCYRRHIZATECA2Y0FE3FXIACT
CARBOMER0A5MM307FCIACT
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT
COCOS NUCIFERA (COCONUT) OILQ9L0O73W7LIACT
PEG-100 STEARATEYD01N1999RIACT
AZELAIC ACIDF2VW3D43YTIACT
SALICYLIC ACIDO414PZ4LPZACTIB
HYDROXYACETOPHENONEG1L3HT4CMHIACT
GLYCERYL STEARATE230OU9XXE4IACT
OLDENLANDIA CAPENSIS WHOLEZ396QHB97FIACT
ALLANTOIN344S277G0ZIACT
PANTHENOLWV9CM0O67ZIACT
CETEARYL ALCOHOL2DMT128M1SIACT
SODIUM ACRYLATE7C98FKB43HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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
AOSORW Folliculitis and Acne Treatment CreamFOLLICULITIS AND ACNE TREATMENT CREAMSpineStatus LLC3a07f7dd-8159-46b1-e063-6294a90a774b2025-11-03WarningsExact identifier
ndc (package): 85498-012-01
ndc (product): 85498-012
ndc11 (package): 85498001201
spl id: 42b4401d-4283-7409-e063-6394a90aa483
spl set id: 3a07f7dd-8159-46b1-e063-6294a90a774b

Reported adverse events (FAERS/openFDA)#

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