FDA.reportPublic FDA data

MILANI ERASE BASE BLEMISH CONTROL PRIMER Salicylic Acid

Manufacturer
New Milani Group, LLC
Effective date
2023-12-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:04:52

Label at a glance#

ProductMILANI ERASE BASE BLEMISH CONTROL PRIMER Salicylic Acid
Active ingredientSALICYLIC ACID
Label structure7 sections

Indications and uses

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

Dosage and administration

• Clean the skin thoroughly before applying this product • Cover the entire affected area with a thin layer one to three times daily • 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 to once a day or every other day

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away. 

When using this product

OTC - WHEN USING SECTION

• 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.

Directions

DOSAGE & ADMINISTRATION SECTION

• Clean the skin thoroughly before applying this product • Cover the entire affected area with a thin layer one to three times daily • 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 to once a day or every other day


Inactive ingredients:

INACTIVE INGREDIENT SECTION

Water, Tapioca Starch, Aluminum Starch Octenylsucciinate, Propanediol, Glycerin, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Sodium Hydroxide, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Polyglyceryl-4 Caprate, Polyglyceryl-6 Caprylate, Phenoxyethanol, Chondrus Crispus Extract, Caprylyl Glycol, Saccharum Officinarum (Sugarcane) Extract, Polymethyl silsesquioxane, Panthenol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Polysorbate 60, Sorbitan Isostearate, Glycolic Acid, Disodium EDTA.

Questions or comments?

OTC - QUESTIONS SECTION

Call 866-–789–8002 Monday – Friday (7 a.m. to 3:30 p.m. PST)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package2Outer Package2Inner Package2Inner Package2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
317152salicylic acid 2 % Topical CreamPSN3
317152salicylic acid 20 MG/ML Topical CreamSCD3
317152salicylic acid 2 % Topical CreamSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71435-0005-02023-12-18C16284748780-10191ceaa-7201-198a-e063-dbdaa90aec3eMILANI ERASE BASE BLEMISH CONTROL PRIMER 2% Salicylic Acid
71435-0005-02023-07-28C16284748780-10191ceaa-7201-198a-e063-dbdaa90aec3eMILANI ERASE BASE BLEMISH CONTROL PRIMER 2% Salicylic Acid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71435-0005-0MILANI ERASE BASE BLEMISH CONTROL PRIMER Salicylic Acid30 mL in 1 TUBECREAM303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71435-0005MILANI ERASE BASE BLEMISH CONTROL PRIMER SALICYLIC ACID (SALICYLIC ACID) CREAM [NEW MILANI GROUP, LLC]3Current NDC, Legacy NDC, 1 package rows20231219_c2d43609-8a7a-4e54-8e8c-66115948dba2.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71435-000571435-0005-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
STARCH, TAPIOCA24SC3U704IIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
PROPANEDIOL5965N8W85TIACT
GLYCERINPDC6A3C0OXIACT
SODIUM HYDROXIDE55X04QC32IIACT
POLYGLYCERYL-4 CAPRATE3N873UN885IACT
POLYGLYCERYL-6 CAPRYLATEDGV8R54VG7IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CHONDRUS CRISPUS CARRAGEENANUE856F2T78IACT
CAPRYLYL GLYCOL00YIU5438UIACT
SUGARCANE81H2R5AOH3IACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
PANTHENOLWV9CM0O67ZIACT
TEA TREE OILVIF565UC2GIACT
POLYSORBATE 60CAL22UVI4MIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
GLYCOLIC ACID0WT12SX38SIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
SALICYLIC ACIDO414PZ4LPZACTIB

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
MILANI ERASE BASE BLEMISH CONTROL PRIMER Salicylic AcidSALICYLIC ACIDNew Milani Group, LLCc2d43609-8a7a-4e54-8e8c-66115948dba22023-12-12WarningsExact identifier
ndc (package): 71435-0005-0
ndc (product): 71435-0005
ndc11 (package): 71435000500
spl id: 0c5cff9a-f83a-7fae-e063-6294a90a7737
spl set id: c2d43609-8a7a-4e54-8e8c-66115948dba2

Reported adverse events (FAERS/openFDA)#

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