Label: GOODBYE ACNE THERAPEUTIC SULFUR MASK- sulfur paste
- NDC Code(s): 54031-107-02, 54031-107-14, 54031-107-16
- Packager: PETER THOMAS ROTH, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 17, 2025
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
-
WHEN USING
When Using this product
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 one topical acne medication at a time.
- Apply only to areas with Acne
Avoid contact with eyes. If excessive skin irritation develops or increases, discontinue use abd consult a doctor.
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
- Clean skin. Apply to affected areas of face, chest and back.
- Allow mask to dry for 5-10 minutes and rinse thoroughly with water to remove.
- Pat dry.
- Apply 2-3 times per week.
- If bothersome dryness or peeling occurs, reduce frequency of application
- Mask may dry out over time, add a few drops of water if needed.
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INACTIVE INGREDIENT
Inactive Ingredients
Water/Aqua/eau, Propylene Glycol, Glycerin, Bentonite, Kaolin, Aloe Barbadensis Leaf Juice, Titanium Dioxide, Zinc Oxide, Phenoxyethanol, Carbomer, Polysorbate 20, Potassium Sorbate, Sodium benzoate, triethoxycaprylylsilane, Fragrane/Parfum, Citric Acid, Sodium Hyaluronate, Ethylhexylglycerin.
- QUESTIONS
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GOODBYE ACNE THERAPEUTIC SULFUR MASK
sulfur pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54031-107 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 14.458 g in 144.58 g Inactive Ingredients Ingredient Name Strength CARBOMER (UNII: 0A5MM307FC) PHENOXYETHANOL (UNII: HIE492ZZ3T) BENZYL ACETATE (UNII: 0ECG3V79ZJ) WATER (UNII: 059QF0KO0R) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM BENZOATE (UNII: OJ245FE5EU) HEXAMETHYLINDANOPYRAN (UNII: 14170060AT) AMYL SALICYLATE (UNII: VZO9C30208) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ANISALDEHYDE (UNII: 9PA5V6656V) HELIOTROPINE (UNII: KE109YAK00) BENTONITE (UNII: A3N5ZCN45C) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM HYALURONATE (UNII: YSE9PPT4TH) LINALOOL (UNII: D81QY6I88E) ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CITRONELLOL (UNII: P01OUT964K) KAOLIN (UNII: 24H4NWX5CO) BENZYL SALICYLATE (UNII: WAO5MNK9TU) LINALYL ACETATE (UNII: 5K47SSQ51G) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TERPINEOL ACETATE (UNII: NIT9SZT3D7) LIMONENE, (+)- (UNII: GFD7C86Q1W) GLYCERIN (UNII: PDC6A3C0OX) CITRIC ACID (UNII: 2968PHW8QP) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54031-107-14 144.58 g in 1 JAR; Type 0: Not a Combination Product 08/01/2024 2 NDC:54031-107-16 48.19 g in 1 JAR; Type 0: Not a Combination Product 02/01/2024 3 NDC:54031-107-02 144.58 g in 1 CARTON; Type 0: Not a Combination Product 08/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 02/01/2024 Labeler - PETER THOMAS ROTH, LLC (780458944) Registrant - JUNE JACOBS LABS LLC (122610681) Establishment Name Address ID/FEI Business Operations JUNE JACOBS LABS LLC 122610681 manufacture(54031-107)
