SHAANT SPOT HERO DRYING ACNE TREATMENT- sulfur gel

Shaant Spot Hero Drying Acne Treatment by

Drug Labeling and Warnings

Shaant Spot Hero Drying Acne Treatment by is a Otc medication manufactured, distributed, or labeled by Codex Labs Corporation, Port Jervis Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Sulfur 5%

Purpose

Acne treatment

Use

For the treatment of acne.

Warnings

For external use only.

Do not use on

• broken skin
• large areas of the skin

When using this product

• 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.

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

Directions

• 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

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?

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

Info-médicament

Ingrédient actif

Soufre 5%

Utilité

Traitement de l'acné

Utiliser

Pour le traitement de l'acné.

Mises en garde

Pour usage externe uniquement.

Ne pas utiliser sur

• lésions cutanées
• grandes surfaces de la peau

Lorsque vous utilisez ce produit

• 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.

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

Mode d'emploi

• 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

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?

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

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 Tube Label

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

INGREDIENTS AND APPEARANCE

SHAANT SPOT HERO DRYING ACNE TREATMENT 
sulfur gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83196-690
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70)	Sulfur	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
BETULA PUBESCENS BARK (UNII: 3R504894L9)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)
FUCUS SPIRALIS (UNII: 3W9AY2P26F)
TETRASELMIS CHUI (UNII: T9C83Z6363)
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
MALIC ACID (UNII: 817L1N4CKP)
GLYCOLIC ACID (UNII: 0WT12SX38S)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PYRUVIC ACID (UNII: 8558G7RUTR)
TARTARIC ACID (UNII: W4888I119H)
PHYTATE SODIUM (UNII: 88496G1ERL)
OCIMUM TENUIFLORUM LEAF OIL (UNII: KRP8S57T49)
OCTYLDODECANOL (UNII: 461N1O614Y)
POGOSTEMON CABLIN TOP (UNII: 2I2A73IYL7)
COCONUT (UNII: 3RT3536DHY)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
XANTHAN GUM (UNII: TTV12P4NEE)
ZOSTERA MARINA WHOLE (UNII: 5JFW9Q62HN)
LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83196-690-12	1 in 1 CARTON	05/15/2023
1		15 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	05/15/2023

Labeler - Codex Labs Corporation (116975992)

Establishment
Name	Address	ID/FEI	Business Operations
Port Jervis Laboratories, Inc		001535103	MANUFACTURE(83196-690)