ACNE Moisturizer

Manufacturer
MONAT GLOBAL CORP | COSMAX USA, INC
Effective date
2024-01-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:15:01

Label at a glance#

ProductACNE Moisturizer
Active ingredientSALICYLIC ACID
Label structure9 sections

Indications and uses

Uses For the treatment of acne Helps prevent new acne blemishes from forming

Dosage and administration

Directions Clean skin thoroughly before applying this product Apply a dime-sized amount onto fingers. Gently use fingertips to apply to clean and dry face using circular motions 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 ...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT:

Salicylic Acid 2.00%

Purpose

OTC - PURPOSE SECTION

Purpose

Acne Treatment

USES

INDICATIONS & USAGE SECTION

Uses

  • For the treatment of acne
  • Helps prevent new acne blemishes from forming

Warnings

WARNINGS SECTION

Warnings

For external use only

When using this product

OTC - WHEN USING SECTION

When using this product

  • skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne treatment at a time.
  • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and consult

OTC - STOP USE SECTION

Stop use and consult with a doctor if irritation becomes severe

Keep out of reach of children

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 immediately.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Directions

  • Clean skin thoroughly before applying this product
  • Apply a dime-sized amount onto fingers. Gently use fingertips to apply to clean and dry face using circular motions
  • 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 to once a day or every other day.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Dimethyl Isosorbide, Glycerin, Sodium Hydroxide, Cetearyl Olivate, Caprylic/Capric Triglyceride, Lactococcus Ferment Lysate, Niacinamide, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sorbitan Isostearate, Polysorbate 60, Polyacrylate Crosspolymer-6, Sorbitan Olivate, Jojoba Esters, Helianthus Annuus (Sunflower) Seed Wax, Acacia Decurrens Flower Wax, Polyglycerin-3, Tocopherol, Coco-Caprylate/Caprate, Triheptanoin, C9-12 Alkane, Dilinoleic Acid/Butanediol Copolymer, Castor Oil/IPDI Copolymer, Physalis Angulata Extract, Lactic Acid, Sodium Hyaluronate, 1,2-Hexanediol, Polylysine, Camellia Sinensis Leaf Extract, Potassium Sorbate, Sodium Benzoate, Bisabolol, Pentylene Glycol, Propanediol, Caprylyl Glycol, Ethylhexylglycerin, Sodium Chloride, t-Butyl Alcohol, Chlorphenesin, Phenylpropanol, Levulinic Acid, Sodium Levulinate

Questions or comments

OTC - QUESTIONS SECTION

Questions or comments?

Toll-free number 1-800-878-1978

Primary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary PackagePrimary PackagePrimary Package

Secondary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer packageOuter packageSecondary Package

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78518-012-012024-01-11C16284748780-10191ceaa-7299-198a-e063-dbdaa90aec3eMONAT BE CLARIFIED ACNE-CLEARING MOISTURIZER
78518-012-012023-07-28C16284748780-10191ceaa-7299-198a-e063-dbdaa90aec3eMONAT BE CLARIFIED ACNE-CLEARING MOISTURIZER

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78518-012ACNE MOISTURIZER (SALYCILIC ACID) CREAM [MONAT GLOBAL CORP]2Unmatched20240112_f83a5268-d23b-53a9-e053-6294a90a5b34.zip

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78518-01278518-012-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOCOPHEROLR0ZB2556P8IACT
DILINOLEIC ACID/BUTANEDIOL COPOLYMER1F2S8T535OIACT
SODIUM LEVULINATEVK44E1MQU8IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
LEVOMENOL24WE03BX2TIACT
SODIUM CHLORIDE451W47IQ8XIACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
LEVULINIC ACIDRYX5QG61EIIACT
POLY-L-LYSINE (30000-70000 MW)0A1V8JTU2MIACT
NIACINAMIDE25X51I8RD4IACT
PROPANEDIOL5965N8W85TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CHLORPHENESINI670DAL4SZIACT
PHENYLPROPANOL0F897O3O4MIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
PHYSALIS ANGULATAW4TKW9D5GGIACT
HYALURONATE SODIUMYSE9PPT4THIACT
CETEARYL OLIVATE58B69Q84JOIACT
LACTIC ACID33X04XA5ATIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
SALICYLIC ACIDO414PZ4LPZACTIB
TRIHEPTANOIN2P6O7CFW5KIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
SORBITAN OLIVATEMDL271E3GRIACT
HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS)CH428W5O62IACT
POLYGLYCERIN-34A0NCJ6RD6IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PENTYLENE GLYCOL50C1307PZGIACT
SODIUM HYDROXIDE55X04QC32IIACT
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDEU73D397055IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
ACACIA DECURRENS FLOWER WAXAU6XZE9IY9IACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
LACTOCOCCUS LACTISF1A0PSN10VIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT

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
46e0833f-aed5-239f-e063-6294a90a961bf83a5268-d23b-53a9-e053-6294a90a5b342025-12-26WarningsExact identifier
spl set id: f83a5268-d23b-53a9-e053-6294a90a5b34

Reported adverse events (FAERS/openFDA)#

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