FDA.reportPublic FDA data

ACNE SPOT TREATMENT

Manufacturer
CONTROL CORRECTIVE SKINCARE INC
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:29:47

Label at a glance#

ProductACNE SPOT TREATMENT
Active ingredientSALICYLIC ACID
Label structure10 sections

Dosage and administration

APPLY A SMALL AMOUNT WITH FINGERS TO CLEAN, DRY SKIN. MAY BE USED ALL OVER THE AFFECTED AREA OR USED TO SPOT TREAT BLEMISHES. IF ANY DISCOMFORT OCCURS, REDUCE FREQUENCY OR DISCONTINUE USE.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

SALICYLIC ACID (2.0%)

PURPOSE

OTC - PURPOSE SECTION

ACNE TREATMENT

USE

INDICATIONS & USAGE SECTION

AN EXFOLIATING GEL THAT AIDS IN REDUCING ACNE BREAKOUTS.

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY. DO NOT USE ON BROKEN SKIN. AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

APPLY A SMALL AMOUNT WITH FINGERS TO CLEAN, DRY SKIN. MAY BE USED ALL OVER THE AFFECTED AREA OR USED TO SPOT TREAT BLEMISHES. IF ANY DISCOMFORT OCCURS, REDUCE FREQUENCY OR DISCONTINUE USE.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER, GLYCOLIC ACID (3%), SD ALCOHOL 40-A, ALOE BARBADENSIS LEAF JUICE, WITCH HAZEL, GLYCERIN, TRIETHANOLAMINE, METHYL GLUCETH-20, SODIUM LACTATE, FRUCTOSE, UREA, NIACINAMIDE, INOSITOL, SODIUM BENZOATE, LACTIC ACID, HYDROXYETHYLCELLULOSE, PHENOXYETHANOL, PANTHENOL, ALLANTOIN, GLUCOSAMINE SULFATE, METHYLISOTHIAZOLINONE.

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.

OTC - DO NOT USE SECTION

DO NOT USE IF ALLERGIC TO ASPERIN.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b UC_Acne Spot Treatment01b UC_Acne Spot Treatment

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
346298salicylic acid 2 % Topical GelPSN5
346298salicylic acid 0.02 MG/MG Topical GelSCD5
346298salicylic acid 2 % Topical GelSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70764-105-512025-12-31C16284748780-12cef2736-8a4f-d83d-e063-dadaa90ab31fCONTROL CORRECTIVE (70764-105)
70764-105-512025-01-30C16284748780-12cef2736-8a4f-d83d-e063-dadaa90ab31fCONTROL CORRECTIVE (70764-105)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70764-105-11ACNE SPOT TREATMENT30 mL in 1 BOTTLEGEL305
70764-105-51ACNE SPOT TREATMENT1 in 1 BOXGEL15

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
70764-10570764-105-11, 70764-105-51

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
WATER059QF0KO0RIACT
GLYCOLIC ACID0WT12SX38SIACT
ALCOHOL3K9958V90MIACT
ALOE VERA LEAFZY81Z83H0XIACT
WITCH HAZEL101I4J0U34IACT
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
METHYL GLUCETH-20J3QD0LD11PIACT
SODIUM LACTATETU7HW0W0QTIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
FRUCTOSE6YSS42VSEVIACT
UREA8W8T17847WIACT
NIACINAMIDE25X51I8RD4IACT
INOSITOL4L6452S749IACT
SODIUM BENZOATEOJ245FE5EUIACT
LACTIC ACID33X04XA5ATIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PANTHENOLWV9CM0O67ZIACT
ALLANTOIN344S277G0ZIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
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
ACNE SPOT TREATMENTSALICYLIC ACIDCONTROL CORRECTIVE SKINCARE INC11d47f80-02ae-44a6-acf1-3babb762967b2025-12-31WarningsExact identifier
ndc (package): 70764-105-11
ndc (package): 70764-105-51
ndc (product): 70764-105
ndc11 (package): 70764010511
ndc11 (package): 70764010551
spl id: 474bb8a5-0d4f-2e4b-e063-6394a90ac399
spl set id: 11d47f80-02ae-44a6-acf1-3babb762967b

Reported adverse events (FAERS/openFDA)#

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