GOODBYE ACNE THERAPEUTIC SULFUR MASK- sulfur paste

GOODBYE ACNE THERAPEUTIC SULFUR MASK by

Drug Labeling and Warnings

GOODBYE ACNE THERAPEUTIC SULFUR MASK by is a Otc medication manufactured, distributed, or labeled by PETER THOMAS ROTH, LLC, JUNE JACOBS LABS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

SULFUR 10%................................................................Acne Treatment

INDICATIONS & USAGE

USES

• For the treatment and management of acne.
• Clears up active acne blemishes and blackheads.
• Helps to prevent new acne blemishes and blackheads.

WARNINGS

WARNINGS

For external use only.

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

Do not use on

• Broken skin
• Large areas of the skin

KEEP OUT OF REACH OF CHILDREN

If product is swallowed, get medical help or contact a Poison Control Center right away.

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.

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

Questions or Comments?

Call toll free 1-800-PTR-SKIN (787-7546)

PURPOSE

Sulfur 10%..................................................................................Acne treatment

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GOODBYE ACNE THERAPEUTIC SULFUR MASK 
sulfur paste

Product 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)