FDA.reportPublic FDA data

MDacne Customized Acne Treatment Cream Salicylic Acid 2%

Manufacturer
MDAlgorithms Inc
Effective date
2024-09-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:19:52

Label at a glance#

ProductMDacne Customized Acne Treatment Salicylic Acid
Active ingredientSALICYLIC ACID
Label structure8 sections

Dosage and administration

Cleanse the skin thoroughly before applying medication. Apply even layer over affected area. Do not use on broken skin or large parts of the body. *For best results apply one to three times per day.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2.0%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Use For:

INDICATIONS & USAGE SECTION

For the treatment of Acne. Clears up acne pimples and blemishes, and allows skin to heal. Helps prevent new pimples and blemishes from forming.

Warnings:

WARNINGS SECTION

For external use only.

  • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin.
  • Because excessive drying of the skin may occur, start with one use daily. Gradually increase to two times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once per day.

•  Do not use 

OTC - DO NOT USE SECTION

for prolonged periods without consulting a doctor.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, contact physician or poison control center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

Cleanse the skin thoroughly before applying medication. Apply even layer over affected area. Do not use on broken skin or large parts of the body. *For best results apply one to three times per day.

Other information:

SPL UNCLASSIFIED SECTION

Store in a cool, dry place below 20ºC (70ºF).

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbic Acid (Vitamin C), C12 15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Extract, Cetearyl Alcohol, Cucumis Sativus (Cucumber) Fruit Extract, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glyceryl Stearate SE, Glycyrrhiza Glabra (Licorice) Root Extract, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Lavandula Angustifolia (Lavender) Oil, Magnesium Aluminum Silicate, PEG 100 Stearate, Phenoxyethanol, Polysorbate 80, Propylene Glycol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol.

Questions:

OTC - QUESTIONS SECTION

Contact us at support@mdacne.com

Package Labelling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label04.jpgLabel04.jpgLabel05.jpgLabel05.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
317152salicylic acid 2 % Topical CreamPSN1
317152salicylic acid 20 MG/ML Topical CreamSCD1
317152salicylic acid 2 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71804-533-00MDacne Customized Acne Treatment Salicylic Acid15 mL in 1 TUBECREAM151
71804-533-00MDacne Customized Acne Treatment Salicylic Acid1 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71804-533MDACNE CUSTOMIZED ACNE TREATMENT SALICYLIC ACID (SALICYLIC ACID) CREAM [MDALGORITHMS INC]1Current NDC, 2 package rows20240921_3eae8b39-d2c2-4cf7-8c56-7fbaec481fc7.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71804-53371804-533-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CUCUMBERYY7C30VXJTIACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
LAVENDER OILZBP1YXW0H8IACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
EDETATE SODIUMMP1J8420LUIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CORN0N8672707OIACT
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
MDacne Customized Acne Treatment Salicylic AcidSALICYLIC ACIDMDAlgorithms Inc3eae8b39-d2c2-4cf7-8c56-7fbaec481fc72024-09-19WarningsExact identifier
ndc (package): 71804-533-00
ndc (product): 71804-533
ndc11 (package): 71804053300
spl id: 2275b141-373f-ba7f-e063-6294a90af5c5
spl set id: 3eae8b39-d2c2-4cf7-8c56-7fbaec481fc7

Reported adverse events (FAERS/openFDA)#

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