ACNE THERAPY MOISTURIZING- salicylic acid cream

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 Anti Acne Care Cream offers a soothing formula that helps block the recurrence of acne symptoms with the help of SALICYLIC ACID

PREVENTS:
Excessive sebum secretion

RELIEVES:
Itching, inflammation, and roughness

CONTROLS:
Flaking and scaling

HELPS BLOCK:
Recurrence of acne symptoms

Active ingredient

Salicylic Acid 1.5%

Active ingredient

Salicylic Acid 1.5%

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Extract, Azelaic Acid, Benzoic
Acid, a-Bisabolol, Cetyl Alcohol, Chloroxylenol, Dehydroacetic
Acid, Di-C12-13 Alkyl Malate, Dipropylene Glycol, Distilled
Water, Glyceryl Monostearate, Hydrogen Peroxide, Laureth-9,
Mentha Piperita Extract, Octyldodecanol, Panthenol, Paraffinum
Liquidum, Phenoxyethanol, Urea, Xanthan Gum, Zinc Oxide

Directions

• Cleanse the skin thoroughly before applying the product
• Apply to affected areas with a thin layer, one to three times daily or as directed by a doctor

Use

For the treatment of acne
Helps prevent new acne pimples from forming

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

Do not use

• For prolonged periods of time without consulting a doctor
• On large or deep wounds
• On damaged or irritated skin not caused by acne
• On healthy skin
• In or around the rectum, genital area, or on the groin unless advised by a doctor

Ask a doctor before use if

Condition covers a large area of the body

Stop use and ask a doctor if

Excessive skin irritation/allergic reaction occurs, condition worsens or does not improve after regular use of this product as directed.

Keep out of reach of children

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

Questions or Comments

1 844 4PSODEX | info@psodexusa.com

Other information

Store at controlled room temperature 59-86°F

Warnings

For external use only

Purpose

Acne treatment

When using this product

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACNE THERAPY  MOISTURIZING
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73503-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LEVOMENOL (UNII: 24WE03BX2T)	2 g  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.5 g  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	5 g  in 100 mL
POLIDOCANOL (UNII: 0AWH8BFG9A)	3 g  in 100 mL
OCTYLDODECANOL (UNII: 461N1O614Y)	2 g  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	1 g  in 100 mL
UREA (UNII: 8W8T17847W)	5 g  in 100 mL
MENTHA PIPERITA LEAF (UNII: A389O33LX6)	5 g  in 100 mL
PANTHENOL (UNII: WV9CM0O67Z)	1 g  in 100 mL
MINERAL OIL (UNII: T5L8T28FGP)	5 g  in 100 mL
DEHYDROACETIC ACID (UNII: 2KAG279R6R)	0.25 g  in 100 mL
CHLOROXYLENOL (UNII: 0F32U78V2Q)	0.5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z)	5 g  in 100 mL
XANTHAN GUM (UNII: TTV12P4NEE)	0.3 g  in 100 mL
ALLANTOIN (UNII: 344S277G0Z)	2 g  in 100 mL
CETYL ALCOHOL (UNII: 936JST6JCN)	5 g  in 100 mL
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)	2 g  in 100 mL
DIPROPYLENE GLYCOL (UNII: E107L85C40)	0.2 g  in 100 mL
BENZOIC ACID (UNII: 8SKN0B0MIM)	0.25 g  in 100 mL
DI-C12-13 ALKYL MALATE (UNII: RRL7C51WPD)	2 g  in 100 mL
AZELAIC ACID (UNII: F2VW3D43YT)	3 g  in 100 mL
WATER (UNII: 059QF0KO0R)	43.5 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73503-008-01	1000 in 1 BOX	01/01/2024
1	NDC: 73503-008-00	1000 mL in 1 BOTTLE, PUMP; 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	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(73503-008)