FDA.reportPublic FDA data

Salicylic Acid

Manufacturer
D3 Development, Inc.
Effective date
2018-05-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:27

Label at a glance#

ProductSalicylic Acid
Active ingredientSALICYLIC ACID
Label structure13 sections

Storage and handling

Other information Store at room temperature Lot number and expiration date are printed on back panel.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Salicylic acid 2%

OTC - PURPOSE SECTION

Purpose

Acne treatment

INDICATIONS & USAGE SECTION

Uses

  • For the treatment of acne
  • Reduces the number of acne pimples and allows skin to heal
  • Penetrates pores to clear most acne blemishes
  • Dries up acne pimples
  • Helps keep skin clear of new acne blemishes, acne pimples, whiteheads, and blackheads

WARNINGS SECTION

Warnings

For external use only

OTC - WHEN USING SECTION

When using this product, skin irritation and dryness may occur if you use other topical acne medications at the same time or immediately following use of this product. If this occurs, use only one medication at a time unless directed by a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Apply liberally over wet skin with a clean wash cloth or body puff, concentrating on areas prone to acne, avoiding contact with eyes.
  • Rinse thoroughly and pat dry with a clean towel
  • Because bothersome dryness of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day

STORAGE AND HANDLING SECTION

Other information

  • Store at room temperature
  • Lot number and expiration date are printed on back panel.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Sodium palmate, sodium cocoate*, sodium palm kernelate*, water, glycerin, titanium dioxide, table salt, olive oil, Avena Sativa (oat) kernel flour, pentasodium pentetate, tocopheryl acetate (vitamin E)

SPL UNCLASSIFIED SECTION

Distributed by:

D3 Development, Inc., Portland, ME 04101

Made in the USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dermaharmony

Salicylic Acid SOAP

For Acne, Whiteheads, & Blackheads

NET WT 4.0 OZ (113 G)

SalicylicAcid-FINAL 05-07-18SalicylicAcid-FINAL 05-07-18

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
562600salicylic acid 2 % Medicated Liquid SoapPSN1
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD1
562600salicylic acid 2 % Facial Cleanser TonerSY1
562600salicylic acid 2 % Facial ScrubSY1
562600salicylic acid 2 % Medicated Liquid SoapSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71819-003-04Salicylic Acid113 g in 1 CELLO PACKSOAP1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71819-003SALICYLIC ACID SOAP [D3 DEVELOPMENT, INC.]1Current NDC, Legacy NDC, 1 package rows20180508_6b650f3d-a242-7a30-e053-2991aa0a777e.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71819-00371819-003-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
SODIUM COCOATER1TQH25F4IIACT
GLYCERINPDC6A3C0OXIACT
SALICYLIC ACIDO414PZ4LPZACTIB
OATMEAL8PI54V663YIACT
SODIUM PALM KERNELATE6H91L1NXTWIACT
OLIVE OIL6UYK2W1W1EIACT
SODIUM PALMATES0A6004K3ZIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
PENTASODIUM PENTETATE961TOZ5L7TIACT

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
Salicylic AcidSALICYLIC ACIDD3 Development, Inc.6b650f3d-a242-7a30-e053-2991aa0a777e2018-05-04WarningsExact identifier
ndc (package): 71819-003-04
ndc (product): 71819-003
ndc11 (package): 71819000304
spl id: 6b650f3d-a243-7a30-e053-2991aa0a777e
spl set id: 6b650f3d-a242-7a30-e053-2991aa0a777e

Reported adverse events (FAERS/openFDA)#

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