FDA.reportPublic FDA data

ALA-SEPTIC Lotion

Manufacturer
Ala-Septic Pharmaceutical Research LLC
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:46:25

Label at a glance#

ProductALA-SEPTIC
Active ingredientSALICYLIC ACID
Label structure6 sections

Dosage and administration

Apply to affected areas one to four times daily or as directed by a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2.00%

Purpose

OTC - PURPOSE SECTION

Seborrheic Dermatitis, Psoriasis

Use For:

INDICATIONS & USAGE SECTION

For relief of the symptoms of seborrheic dermatitis and psoriasis.

Warning:

WARNINGS SECTION

  • For external use only.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Ask a doctor before using this product if

OTC - ASK DOCTOR SECTION

  • condition covers a large area of the body

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or does not improve after regular use of this product as directed.

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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Apply to affected areas one to four times daily or as directed by a doctor.

Other Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzoic Acid, Butylene Glycol, C13-14 Isoparaffin, Ethylhexylglycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Iodoquinol, Isopropyl Myristate, Larrea Tridentata Extract, Laureth-7, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Phenoxyethanol, Polyacrylamide, Polysorbate-20, SD-Alcohol 40B, Tocopheryl Acetate (Vitamin-E).

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottleLabelLabel

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59434-13459434-134-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
BENZOIC ACID8SKN0B0MIMIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
IODOQUINOL63W7IE88K8IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LARREA TRIDENTATA LEAFPK0TXD049PIACT
LAURETH-7Z95S6G8201IACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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
291e36e9-f82f-ee17-e063-6294a90aa2527e57c341-ca95-4b5b-8692-c6c008e52d752024-12-12WarningsExact identifier
spl id: 291e36e9-f82f-ee17-e063-6294a90aa252
spl set id: 7e57c341-ca95-4b5b-8692-c6c008e52d75

Reported adverse events (FAERS/openFDA)#

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