Label: SHAANT SPOT HERO DRYING ACNE TREATMENT- sulfur gel
- NDC Code(s): 83196-690-12
- Packager: Codex Labs Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 9, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
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Warnings
For external use only.
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.
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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.
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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?
- Ingrédient actif
- Utilité
-
Utiliser
Pour le traitement de l'acné.
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.
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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.
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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
- Principal Display Panel – 15 mL Tube Label
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INGREDIENTS AND APPEARANCE
SHAANT SPOT HERO DRYING ACNE TREATMENT
sulfur gelProduct 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 final part333D 05/15/2023 Labeler - Codex Labs Corporation (116975992) Establishment Name Address ID/FEI Business Operations Port Jervis Laboratories, Inc 001535103 MANUFACTURE(83196-690)
