ACNE THERAPY BAR- sulfur soap

Acne Therapy by

Drug Labeling and Warnings

Acne Therapy by is a Otc medication manufactured, distributed, or labeled by PSODEX USA INC, BERKO ILAC VE KIMYA SANAYI ANONIM SIRKETI-SULTANBEYLI SUBESI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Acne is a common skin condition that can fluctuate over time.

The main goal of treatment is to manage symptoms.

PSODEX Acne Therapy Soap Bar offers a soothing formula that helps block the recurrence of acne symptoms with the help of SULFUR.

PREVENTS:
Excessive sebum secretion

RELIEVES:
Itching, inflammation, and roughness

CONTROLS:
Flaking and scaling

HELPS BLOCK:
Recurrence of acne symptoms

Active Ingredient / Purpose

Active ingredient: Sulfur 3%

Purpose: Acne treatment

ACTIVE INGREDIENT

​Active ingredient: Sulfur 3%

Purpose: Acne treatment

PURPOSE

Purpose: Acne treatment

Inactive Ingredients

Aloe Barbadensis Extract,
Allantoin, Benzalkonium Chloride, Camellia Sinensis Extract,
Citric Acid, Colloidal Oatmeal, Distilled Water, Glycerin,
Mentha Piperita Leaf Extract, Melaleuca Alternifolia Leaf Oil,
Permethrin, Sodium Chloride, Sodium Citrate, Sodium
Laurate, Sodium Stearate, Sorbitol, Tetrasodium Etidronate

USE

Use: For the treatment of acne

INFORMATION FOR OWNERS/CAREGIVERS

DISTRIBUTED BY: Psodex USA Inc.

9898 Bissonnet St Ste 625 Houston, TX 77036

1-844 4PSODEX www.psodexusa.com

MANUFACTURED FOR

Yesim Derma Laboratories

Directions:

Wet affected area with warm water. Foam the soap in hands and apply to the affected area. Massage gently into the skin for 10-20 seconds, then rinse thoroughly. Use up to 2 times per day or as directed by a doctor. Avoid excessive drying of the skin by limiting the

time of contact to 10 seconds or less each time

Ask a doctor before use if:

You are pregnant or breastfeeding.

​Ask a doctor before use if:

You are pregnant or breastfeeding.

Stop use and ask a doctor if:

Condition worsens or does not improve after regular use of this product as directed.

Questions or Comments:

1 844 4PSODEX | info@psodexusa.com

Keep out of reach of children:

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

Do not use :

On damaged or irritated skin not caused by acne or on the sensitive skin

When using this product :

Avoid contact with hair and dyed fabrics, which may be bleached by this product.
Skin irritation may occur. Start with one application daily, then gradually increase to two times daily if needed, or as directed by a doctor

Other information :

Store at controlled room temperature 59-86°F

Warnings:

For external use only

Acne Therapy Soap Bar

INGREDIENTS AND APPEARANCE

ACNE THERAPY  BAR
sulfur soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73503-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)	10 g  in 100 g
TEA LEAF OIL (UNII: VC855RRT77)	5 g  in 100 g
PERMETHRIN (UNII: 509F88P9SZ)	1 g  in 100 g
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)	0.25 g  in 100 g
ALLANTOIN (UNII: 344S277G0Z)	2 g  in 100 g
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)	1 g  in 100 g
SODIUM CHLORIDE (UNII: 451W47IQ8X)	0.25 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)	0.1 g  in 100 g
MENTHA PIPERITA LEAF (UNII: A389O33LX6)	7 g  in 100 g
SODIUM LAURATE (UNII: K146MR5EXO)	10 g  in 100 g
ALOE VERA LEAF (UNII: ZY81Z83H0X)	7 g  in 100 g
OATMEAL (UNII: 8PI54V663Y)	2 g  in 100 g
SODIUM CITRATE (UNII: 1Q73Q2JULR)	0.25 g  in 100 g
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.25 g  in 100 g
WATER (UNII: 059QF0KO0R)	17 mL  in 100 g
SODIUM STEARATE (UNII: QU7E2XA9TG)	10 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	23.9 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73503-013-00	1000 g in 1 BOX; Type 0: Not a Combination Product	01/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	01/01/2024

Labeler - PSODEX USA INC (076051073)

Registrant - PSODEX USA INC (076051073)

Establishment
Name	Address	ID/FEI	Business Operations
BERKO ILAC VE KIMYA SANAYI ANONIM SIRKETI-SULTANBEYLI SUBESI		533135007	manufacture(73503-013)