FDA.reportPublic FDA data

LACTO-S

Manufacturer
Noon Aesthetics M.R. Ltd
Effective date
2024-05-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:01:38

Label at a glance#

ProductLACTO-S ACNE TREATMENT
Active ingredientSALICYLIC ACID
Label structure10 sections

Indications and uses

Use for the treatment of Acne.

Dosage and administration

Cleanse 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, if needed or as directed by a doctor. 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 of peeling occurs, reduce application to one a day o...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

INDICATIONS & USAGE SECTION

  • Use for the treatment of Acne.

Warnings

WARNINGS SECTION

For external use only.

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Cleanse 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, if needed or as directed by a doctor. 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 of peeling occurs, reduce application to one a day or every other day.

Other Information

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Lactic Acid, Propanediol, Dimethyl Sulfone, Strontium Chloride Hexahydrate, Polyacrylate Crosspolymer-6, Isononyl Isononanoate, Ethylhexyl Stearate, Citronellyl Methylcrotonate, Polysorbate 20, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Wheat Straw Glycosides, Cetearyl Alcohol, Cyclopentasiloxane, Dimethicone, T-Butyl Alcohol, Sodium Phytate, Xanthan Gum, Phenoxyethanol, Caprylyl Glycol, Parfum, Sodium Hydroxide, Alcohol, Limonene.

SPL UNCLASSIFIED SECTION

Developed + Dist by
noon
AESTHETICS
TLV, 62153 | Made in Israel
noonaesthetics.com

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

no
on
AESTHETICS

Lacto-S
ACNE TREATMENT

+ DERMSHIELD™

NDC 78863-3001-2

50 mL / 1.75 Fl. Oz. ℮

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78863-3001-1LACTO-S ACNE TREATMENT1 in 1 CARTONCREAM11
78863-3001-1LACTO-S ACNE TREATMENT15 mL in 1 BOTTLE, PUMPCREAM151
78863-3001-2LACTO-S ACNE TREATMENT1 in 1 CARTONCREAM11
78863-3001-2LACTO-S ACNE TREATMENT50 mL in 1 TUBECREAM501
78863-3001-3LACTO-S ACNE TREATMENT200 mL in 1 BOTTLE, PUMPCREAM2001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78863-3001LACTO-S ACNE TREATMENT (SALICYLIC ACID) CREAM [NOON AESTHETICS M.R. LTD]1Current NDC, 5 package rows20250529_ea0c7fda-30a0-48df-8a1b-4d6098c0081e.zip

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
78863-300178863-3001-2, 78863-3001-1, 78863-3001-3

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
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
STRONTIUM CHLORIDE HEXAHYDRATEO09USB7Z44IACT
POLYACRYLIC ACID (450000 MW)KD3S7H73D3IACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
CITRONELLYL METHYLCROTONATEK61O222P3DIACT
POLYSORBATE 207T1F30V5YHIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
PEG-100 STEARATEYD01N1999RIACT
CETEARYL WHEAT STRAW GLYCOSIDESB44PS4T8INIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONE92RU3N3Y1OIACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
PHYTATE PERSODIUM3F6PM8J684IACT
XANTHAN GUMTTV12P4NEEIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
FRAGRANCE 135765EM498GW35IACT
SODIUM HYDROXIDE55X04QC32IIACT
ALCOHOL3K9958V90MIACT
LIMONENE, (+/-)-9MC3I34447IACT

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
LACTO-S ACNE TREATMENTSALICYLIC ACIDNoon Aesthetics M.R. Ltdea0c7fda-30a0-48df-8a1b-4d6098c0081e2024-05-31WarningsExact identifier
ndc (package): 78863-3001-1
ndc (package): 78863-3001-2
ndc (package): 78863-3001-3
ndc (product): 78863-3001
ndc11 (package): 78863300103
ndc11 (package): 78863300101
ndc11 (package): 78863300102
spl id: f2893731-a304-4440-a7ed-264d2fa76c02
spl set id: ea0c7fda-30a0-48df-8a1b-4d6098c0081e

Reported adverse events (FAERS/openFDA)#

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