FDA.reportPublic FDA data

ACTIVE INGREDIENT

Manufacturer
OL PHARMA TECH, LLC Drs. PHARMACY | OL PHARMA TECH, LLC Drs PHARMACY
Effective date
2026-07-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-07-17 21:45:47

Label at a glance#

ProductDrs. ACNE SPOT TREATMENT
Active ingredientSALICYLIC ACID
Label structure12 sections

Indications and uses

For the treatment of acne. Dries and clears acne pimples, blackheads and whiteheads and allows skin to heal.

Dosage and administration

Morning and evening, after a thorough cleansing of the skin, apply acne clear gel locally on cutanous imperfections. Then apply the usual day or night cream. Renew application 1 to 3 times daily.

Storage and handling

store at 15-30 C ( 59-86 F) close cap tightly after use keep away from heat

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2% w/w.

PURPOSE

OTC - PURPOSE SECTION

Acne treatment

USES

INDICATIONS & USAGE SECTION

For the treatment of acne. Dries and clears acne pimples, blackheads and whiteheads and allows skin to heal.

DO NOT USE

OTC - DO NOT USE SECTION

if you have sensitive skin or are sensitive to salicylic acid

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Morning and evening, after a thorough cleansing of the skin, apply acne clear gel locally on cutanous imperfections. Then apply the usual day or night cream. Renew application 1 to 3 times daily.

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. If this occurs, only one medication should be used unless directed by a doctor. Avoid direct contact with the eyes. If product gets into the eyes, rinse liberally with water. Discontinue use if skin irritation develops or increases. If irritation persists, consult a doctor.

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

Avoid contact with eyes, lips, and mouth.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if swallowed, get medical help or contact poison control center right away

INACTIVE INGREDIENT SECTION

carbomer interpolymer type A, trolamine, vitamin E, propylene glycol, water, isopropyl alcohol, methyl paraben, EDTA, propyl paraben, DMDM hydantoin

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • store at 15-30 C ( 59-86 F)
  • close cap tightly after use
  • keep away from heat

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ACNE SPOT TREATMENTACNE SPOT TREATMENT

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80489-357-012026-01-29C16284748780-149896155-cd46-586f-e063-e6dba90add90161b2306-364a-e1b8-e063-6394a90a6c88
80489-357-012026-01-29C16284748780-149896155-cd46-586f-e063-e6dba90add90161b2306-364a-e1b8-e063-6394a90a6c88
80489-357-022026-01-29C16284748780-149896155-cd46-586f-e063-e6dba90add90161b2306-364a-e1b8-e063-6394a90a6c88
80489-357-022026-01-29C16284748780-149896155-cd46-586f-e063-e6dba90add90161b2306-364a-e1b8-e063-6394a90a6c88

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80489-35780489-357-01, 80489-357-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
METHYLPARABENA2I8C7HI9TIACT
SALICYLIC ACIDO414PZ4LPZACTIB
EDETATE DISODIUM7FLD91C86KIACT
TROLAMINE9O3K93S3TKIACT
ISOPROPYL ALCOHOLND2M416302IACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-04-15full-release2026-06-01 00:11:03

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
Drs. ACNE SPOT TREATMENTSALICYLIC ACIDOL PHARMA TECH, LLC Drs. PHARMACY161b2306-364a-e1b8-e063-6394a90a6c882026-07-09WarningsExact identifier
ndc (package): 80489-357-02
ndc (package): 80489-357-01
ndc (product): 80489-357
ndc11 (package): 80489035701
ndc11 (package): 80489035702
spl id: 56368d1e-55eb-bf6c-e063-6294a90a4a90
spl set id: 161b2306-364a-e1b8-e063-6394a90a6c88

Reported adverse events (FAERS/openFDA)#

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