FDA.reportPublic FDA data

Glycare Acne Gel

Manufacturer
MD Formulation | Harmony Labs, Inc.
Effective date
2011-07-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:28:32

Label at a glance#

ProductGlycare Acne
Active ingredientSALICYLIC ACID
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 1%

OTC - PURPOSE SECTION

Acne Tratment

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Clears up acne blemishes and helps prevent new acne blemishes.

WARNINGS SECTION

For external use only.

DOSAGE & ADMINISTRATION SECTION

Directions Cleanse skin thoroughly before applying medication.Cover the entire affected area with a thin layer 1 to 3 times dally. Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 to 3 times daily if needed or as directed by a physician. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

INACTIVE INGREDIENT SECTION

 Water (aqua), sd alcohol 40-b, glycolic acid, ammonium glycolate, hydroxypropyl melhylcellulose.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label
Label
Unit Carton
Unit Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
251380salicylic acid 1 % Topical GelPSN3
251380salicylic acid 0.01 MG/MG Topical GelSCD3
251380salicylic acid 1 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66078-035-252019-10-29C16284748780-1960f7f55-da66-8e05-e053-dbdaa90a074aGlycare Acne Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66078-035-25Glycare Acne1 in 1 CARTONGEL13
66078-035-25Glycare Acne54 in 1 CASEGEL543

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66078-035GLYCARE ACNE (GLYCOLIC ACID) GEL [MD FORMULATION]3Legacy NDC, 2 package rows20110706_ea482e54-e5af-4b57-a75f-e8c1f473f965.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ3
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ3
GLYCOLIC ACIDINACTIVE INGREDIENT0WT12SX38S3
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N23
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66078-03566078-035-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
GLYCOLIC ACID0WT12SX38SIACT
HYPROMELLOSE 2208 (15000 MPA.S)Z78RG6M2N2IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYPROMELLOSE 2208 (15000 MPA.S)HYPROMELLOSE 2208 (15000 MPA.S)Z78RG6M2N2TABLET / ORAL375 mgExact identifier — unii candidate
6 equally ranked IID candidates
HYPROMELLOSE 2208 (15000 MPA.S)HYPROMELLOSE 2208 (15000 MPA.S)Z78RG6M2N2CAPSULE, DELAYED RELEASE / ORAL222 mgExact identifier — unii candidate
6 equally ranked IID candidates
HYPROMELLOSE 2208 (15000 MPA.S)HYPROMELLOSE 2208 (15000 MPA.S)Z78RG6M2N2TABLET, FILM COATED, EXTENDED RELEASE / ORAL2640 mgExact identifier — unii candidate
6 equally ranked IID candidates
HYPROMELLOSE 2208 (15000 MPA.S)HYPROMELLOSE 2208 (15000 MPA.S)Z78RG6M2N2TABLET / BUCCAL17 mgExact identifier — unii candidate
6 equally ranked IID candidates
HYPROMELLOSE 2208 (15000 MPA.S)HYPROMELLOSE 2208 (15000 MPA.S)Z78RG6M2N2CAPSULE / ORAL80.25 mgExact identifier — unii candidate
6 equally ranked IID candidates
HYPROMELLOSE 2208 (15000 MPA.S)HYPROMELLOSE 2208 (15000 MPA.S)Z78RG6M2N2TABLET, EXTENDED RELEASE / ORAL4050 mgExact identifier — unii candidate
6 equally ranked IID candidates

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
6e906461-55a1-4620-9406-c0f50cf9d221ea482e54-e5af-4b57-a75f-e8c1f473f9652011-07-05WarningsExact identifier
spl id: 6e906461-55a1-4620-9406-c0f50cf9d221
spl set id: ea482e54-e5af-4b57-a75f-e8c1f473f965

Reported adverse events (FAERS/openFDA)#

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