FDA.reportPublic FDA data

Drug Facts

Manufacturer
Codex Labs Corporation | Port Jervis Laboratories, Inc
Effective date
2025-11-21
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:39:51

Label at a glance#

ProductShaant Spot Hero Drying Acne Treatment
Active ingredientSulfur
Label structure14 sections

Dosage and administration

Clean the skin thoroughly before applying this product cover the entire affected area with a thin layer 1 to 3 times daily because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sulfur 5%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Use

INDICATIONS & USAGE SECTION

For the treatment of acne.

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on

  • broken skin
  • large areas of the skin

When using this product

OTC - WHEN USING SECTION

  • apply only to areas with acne
  • skin irritation and dryness are 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
  • avoid contact with eyes. If contact occurs, flush thoroughly with water.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer 1 to 3 times daily
  • because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Denatured Alcohol, Lactobacillus Ferment, Propanediol, Glycerin, Silybum Marianum Ethyl Ester, Lactobacillus, Dehydroxanthan Gum, Fucus Spiralis (Spiral Wrack) Extract, Tetraselmis Chui Extract, Centella Asiatica Leaf Extract, Sodium Lactate, Sodium PCA, Malic Acid, Glycolic Acid, Lactic Acid, Pyruvic Acid, Tartaric Acid, Hydrolyzed Sodium Hyaluronate, Sodium Phytate, Ocimum Sanctum Leaf Oil, Octyldodecanol, Pogostemon Cablin (Patchouli) Leaf Extract, Cocos Nucifera (Coconut) Fruit Extract, Tocopherol, Sodium Benzoate, Potassium Sorbate, Citric Acid, Xanthan Gum.

Questions?

OTC - QUESTIONS SECTION

Email support@codexlabscorp.com or call 1-855-263-3980

Info-médicament

Ingrédient actif

OTC - ACTIVE INGREDIENT SECTION

Soufre 5%

Utilité

OTC - PURPOSE SECTION

Traitement de l'acné

Utiliser

INDICATIONS & USAGE SECTION

Pour le traitement de l'acné.

Mises en garde

WARNINGS SECTION

Pour usage externe uniquement.

OTC - DO NOT USE SECTION

Ne pas utiliser sur

  • lésions cutanées
  • grandes surfaces de la peau

Lorsque vous utilisez ce produit

OTC - WHEN USING SECTION

  • appliquer uniquement sur les zones concernées par l'acné
  • l'irritation et la sécheresse peuvent apparaître si vous utilisez un autre médicament topique contre l'acné en même temps. En cas d'irritation, n'utilisez qu'un seul médicament topique contre l'acné à la fois.
  • éviter le contact avec les yeux. En cas de contact, rincer abondamment à l'eau.

Garder hors de portée des enfants.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

En cas d'ingestion, consultez un médecin ou contactez immédiatement un centre antipoison.

Mode d'emploi

DOSAGE & ADMINISTRATION SECTION

  • Nettoyez soigneusement la peau avant d'appliquer ce produit
  • couvrir toute la zone concernée avec une fine couche 1 à 3 fois par jour
  • si un dessèchement excessif de la peau survient, commencer par 1 application par jour, puis augmenter progressivement à 2 ou 3 fois par jour si nécessaire ou selon les directives d'un médecin
  • en cas de sécheresse ou de desquamation gênante, réduire l'application à une fois par jour ou tous les deux jours.

Ingrédients inactifs

INACTIVE INGREDIENT SECTION

Eau, Alcool dénaturé, Ferment de lactobacilles, Propanediol, Glycérol, Silybum Marianum ester éthylique, Lactobacillus, Gomme de déhydroxanthane, Fucus Spiralis (Spiral Wrack) Extrait, Extrait de Tetraselmis Chui, Extrait de feuille de Centella Asiatica, Sodium Lactate, Sodium PCA, Acide malique, Acide glycolique, Acide lactique, Acide pyruvique, Acide tartrique, Hyaluronate de sodium hydrolysé, Sodium Phytate, Huile de feuille d'Ocimum Sanctum, Octyldodécanol, Pogostemon Cablin (Patchouli) Extrait de feuille, Cocos Nucifera (noix de coco) Extrait de fruit, Tocophérol, Sodium Benzoate, Potassium Sorbate, Acide citrique, Gomme xanthane.

Questions?

OTC - QUESTIONS SECTION

Messagerie électronique support@codexlabscorp.com ou composez le 1-855-263-3980

Made in the USA of domestic and imported materials

Manufactured for

Fabriqué par

Codex Labs Corp.

San Jose, CA 95124 USA

codexlabscorp.com

This product is covered by patent(s) or other intellectual

property right(s); see codexlabscorp.com/IP for more details.

Principal Display Panel – 15 mL Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CODEX
LABS™

SHAANT

SPOT HERO

Drying Gel Acne Treatment

Sulfur 5%

Gel de Séchage Traitement de l'acné

Soufre 5%

STOP BOUTON

DERMATOLOGIST TESTED

TESTÉ DERMATOLOGIQUEMENT

SERIOUSLY SUSTAINABLE

SÉRIEUSEMENT DURABLE

Principal Display Panel – 15 mL Carton Label
Principal Display Panel – 15 mL Carton Label

Principal Display Panel – 15 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CODEX
LABS™

SHAANT

SPOT HERO

Drying Gel

Sulfur 5%

Gel de Séchage

Soufre 5%

STOP BOUTON

NET WT 0.5 FL. OZ. / POIDS NET 15 mL e

Principal Display Panel – 15 mL Tube Label
Principal Display Panel – 15 mL Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283392sulfur 5 % Topical GelPSN6
283392sulfur 0.05 MG/MG Topical GelSCD6
283392sulfur 5 % Topical GelSY6

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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83196-690-12Shaant Spot Hero Drying Acne Treatment1 in 1 CARTONGEL16
83196-690-12Shaant Spot Hero Drying Acne Treatment15 mL in 1 TUBEGEL156

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83196-69083196-690-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
Sulfur70FD1KFU70ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
BETULA PUBESCENS BARK3R504894L9IACT
PROPANEDIOL5965N8W85TIACT
GLYCERINPDC6A3C0OXIACT
DEHYDROXANTHAN GUM63ZP7I1BQOIACT
FUCUS SPIRALIS3W9AY2P26FIACT
TETRASELMIS CHUIT9C83Z6363IACT
CENTELLA ASIATICA LEAF6810070TYDIACT
SODIUM LACTATETU7HW0W0QTIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
MALIC ACID817L1N4CKPIACT
GLYCOLIC ACID0WT12SX38SIACT
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATIACT
HYALURONATE SODIUMYSE9PPT4THIACT
PYRUVIC ACID8558G7RUTRIACT
TARTARIC ACIDW4888I119HIACT
PHYTATE SODIUM88496G1ERLIACT
OCIMUM TENUIFLORUM LEAF OILKRP8S57T49IACT
OCTYLDODECANOL461N1O614YIACT
POGOSTEMON CABLIN TOP2I2A73IYL7IACT
COCONUT3RT3536DHYIACT
TOCOPHEROLR0ZB2556P8IACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
XANTHAN GUMTTV12P4NEEIACT
ZOSTERA MARINA WHOLE5JFW9Q62HNIACT
LACTOBACILLUS ACIDOPHILUS1PRR1V42V5IACT
SILYBUM MARIANUM ETHYL ESTERF58HDD7DYHIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-11-18full-release2026-06-01 00:37:55

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
Shaant Spot Hero Drying Acne TreatmentSULFURCodex Labs Corporation24fa844b-e4ce-46de-a2d6-e9e863888a552025-11-21WarningsExact identifier
ndc (package): 83196-690-12
ndc (product): 83196-690
ndc11 (package): 83196069012
spl id: a6542024-a45e-4732-9a12-e7a363e04dd8
spl set id: 24fa844b-e4ce-46de-a2d6-e9e863888a55

Reported adverse events (FAERS/openFDA)#

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