Smart Release Mandelic

Manufacturer
SkinClinical AI, LLC
Effective date
2019-06-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:59:50

Label at a glance#

ProductSmart Release Mandelic 8 PERCENT
Active ingredientSALICYLIC ACID
Label structure10 sections

Dosage and administration

Important to use on a clean face, Cover the affected area with a thin layer 1 to 3 times per day. Because of excessive drying of the skin may occur, start with 1 application per day then gradually increase to 2 applications per day, one morning and one evening ff needed, or as directed by a doctor. If dryness or peeling occurs, reduce use to once a day or once every other day. If going outside, use a sunscreen. if...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

SALICYLIC ACID  .5%

PURPOSE

OTC - PURPOSE SECTION

TREATMENT OF ACNE

USE

INDICATIONS & USAGE SECTION

FOR THE TREATMENT OF ACNE

WARNINGS

WARNINGS SECTION

For External Use Only.

Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.

If irritation occurs, only use 1 topical acne medication at a time.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Keep tightly closed.
Protect from excessive heat (40°/ 140° F) and protect from freezing.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or sensitivity develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poisorl fontrol Center right away. This product contains Mandelic Acid that may increase. Your skin's sensitivity to the sun and the possibility of sunburn. Use a sunscreen, wear protective clothing and limit exposure to the sun using this product and for one week after you stop. Store at room temperature.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Important to use on a clean face, Cover the affected area with a thin layer 1 to 3 times per day. Because of excessive drying of the skin may occur, start with 1 application per day then gradually increase to 2 applications per day, one morning and one evening ff needed, or as directed by a doctor. If dryness or peeling occurs, reduce use to once a day or once every other day. If going outside, use a sunscreen. if irritation or sensitivity develops stop using both products and ask a doctor.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water (Agua), SD Alcohol 40-B, Mandelic Acid, Butylene Glycol,Hamamelis Virginiana (Witch Hazel) Leaf Water, Lactobacillus Ferment, PEG-8 SMDI Copolymer, Niacinamide, Lactic Acid, Sodium PCA, Sodium Lactate, Hydrolyzed Algin, Zinc Sulfate, Glycerin, Opuntia Ficus lndica (Nopal Cactus), Saccharomyces Cerevisiae (Yeast) Extract, Hydroxyethylcellulose, Vaccinium Myrtillus Fruit Extract, Saccharum Officinarum (Sugar Cane) Extract, Acer Saccharum (Sugar Maple) Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Limon (Lemon) Fruit Extract, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Grandis (Grapefruit) Peel Oi!, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Tangerina (Tangerine) Peel Oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_SC_AI_Smart Release Mandelic 8pct01b LBL_SC_AI_Smart Release Mandelic 8pct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
252296salicylic acid 0.5 % Topical GelPSN3
252296salicylic acid 0.005 MG/MG Topical GelSCD3
252296salicylic acid 0.5 % Topical GelSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73110-103-112021-01-29C16284748780-1ba0f9c33-59d9-a910-e053-dadaa90a0b85Smart Release Mandelic 8%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73110-103-11Smart Release Mandelic8 PERCENT30 mL in 1 BOTTLE, DISPENSINGGEL303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73110-103SMART RELEASE MANDELIC 8 PERCENT (SALICYLIC ACID) GEL [SKINCLINICAL AI, LLC]3Legacy NDC, 1 package rows20190709_8d2fa61a-033b-625d-e053-2a95a90aa0c6.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73110-10373110-103-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

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
8d2f82c1-47e0-7791-e053-2a95a90af0158d2fa61a-033b-625d-e053-2a95a90aa0c62019-06-29WarningsExact identifier
spl id: 8d2f82c1-47e0-7791-e053-2a95a90af015
spl set id: 8d2fa61a-033b-625d-e053-2a95a90aa0c6

Reported adverse events (FAERS/openFDA)#

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