Bioelements

Manufacturer
Bioelements
Effective date
2010-06-11
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 20:08:38

Label at a glance#

ProductBioelements Active Astringent
Active ingredientSALICYLIC ACID
Label structure2 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                  Purpose

Salicylic Acid  0.5%               Acne Treatment

INDICATIONS & USAGE SECTION

Uses:

-For the treatment of acne

-Helps prevent new acne blemishes


Directions

-Cleanse skin thoroughly before applying

-Apply to cotton pad and wipe over skin, avoiding eye area.

WARNINGS SECTION

Warnings

-For external use only

-When using this product: Using other topical acne medication at the same time or immediately following the 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. If sensitive to the sun or when increased sun exposure is expected use a sunscreen when using this and other acne products.

-Keep out of reach of children. If swallowed, get medical help or contact poison center right away.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water (Aqua) (Eau), Hamamelis Virginiana (Witch Hazel) Extract, SD Alcohol, Pentylene Glycol, Hexylene Glycol, Glycerin, Vitis Vinifera (Grape) Fruit Extract, Mel (Honey) Extract (Miel Extrait de mile), Potassium Hydroxide, Actinidia Chinensis (Kiwi) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Anenas Sativus (Pineapple) Fruit Extract, Lavandula Angustifolia (Lavender) Extract, Citrus Medica Limonum (Lemon) Fruit Extract, Citrus Aurantifolia (Lime) Fruit Extract, Citrus Aurantium Dulcis (Orange) Oil, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Grandis (Grapefruit) Fruit Extract, Lavendula Hybrida (Lavandin) Oil, Tetrahexadecyl Ascorbate, Methylisothiazolinone, Chlorphenesin

image of back carton
image of back carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bioelements

Acne Clearing System

Active Astringent

88 mL. / 3 Fl. Oz.

image of front labelimage of front label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199308salicylic acid 0.5 % Topical SolutionPSN4
199308salicylic acid 5 MG/ML Topical SolutionSCD4
199308salicylic acid 0.5 % Topical SolutionSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49825-111-022020-01-31C16284748780-19d75b9d0-1eb2-f424-e053-dadaa90a57ceActive Astringent

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49825-111-01BioelementsActive Astringent88 mL in 1 BOTTLELIQUID884
49825-111-02BioelementsActive Astringent1 in 1 BOXLIQUID14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49825-111BIOELEMENTS ACTIVE ASTRINGENT (SALICYLIC ACID) LIQUID [BIOELEMENTS]4Legacy NDC, 2 package rows20100611_2724a67d-0fc6-402c-8aef-d2d76db74f8e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ4
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ4

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49825-11149825-111-01, 49825-111-02

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB

Source Document#

Source XML · Source PDF

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
f9832814-3ee2-457b-aee8-b6fd421b16c42724a67d-0fc6-402c-8aef-d2d76db74f8e2010-06-11WarningsExact identifier
spl id: f9832814-3ee2-457b-aee8-b6fd421b16c4
spl set id: 2724a67d-0fc6-402c-8aef-d2d76db74f8e

Reported adverse events (FAERS/openFDA)#

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