ACNE THERAPY MOISTURIZING- salicylic acid cream 
PSODEX USA INC

----------

Acne Therapy Moisturizing Cream

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

Use

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

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

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.

package

ACNE THERAPY  MOISTURIZING
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73503-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73503-008-011000 in 1 BOX01/01/2024
1NDC:73503-008-001000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00601/01/2024
Labeler - PSODEX USA INC (076051073)
Registrant - PSODEX USA INC (076051073)
Establishment
NameAddressID/FEIBusiness Operations
BERKO ILAC VE KIMYA SANAYI ANONIM SIRKETI-SULTANBEYLI SUBESI533135007manufacture(73503-008)

Revised: 12/2023
Document Id: 0d0ec3bf-47e4-3390-e063-6394a90a38b8
Set id: 0324f485-465f-8b7b-e063-6394a90a9b2c
Version: 2
Effective Time: 20231221
 
PSODEX USA INC