Acne Therapy Moisturizing Cream

Acne Therapy Moisturizing Cream
SPL v2
SPL
SPL Set ID 0324f485-465f-8b7b-e063-6394a90a9b2c
Route
TOPICAL
Published
Effective Date 2024-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Levomenol Phenoxyethanol Aloe Vera Leaf Polidocanol Octyldodecanol Hydrogen Peroxide Urea Mentha Piperita Leaf Panthenol Mineral Oil Dehydroacetic Acid Chloroxylenol Zinc Oxide Xanthan Gum Allantoin Cetyl Alcohol Glyceryl Monostearate Dipropylene Glycol Benzoic Acid Di-c12-13 Alkyl Malate Azelaic Acid Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-01

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

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

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

Use

For the treatment of acne

Helps prevent new acne pimples from forming

Section 50744-2

DISTRIBUTED BY: Psodex USA Inc.

9898 Bissonnet St Ste 625 Houston, TX 77036

1-844 4PSODEX www.psodexusa.com

MANUFACTURED FOR

Yesim Derma Laboratories

Section 51945-4

Warnings

For external use only

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
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
Active Ingredient

Salicylic Acid 1.5%

Other Information

Store at controlled room temperature 59-86°F

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

Questions Or Comments

1 844 4PSODEX | [email protected]

When Using This Product

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

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.


Structured Label Content

Use

For the treatment of acne

Helps prevent new acne pimples from forming

Description (34089-3)

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

Section 50744-2 (50744-2)

DISTRIBUTED BY: Psodex USA Inc.

9898 Bissonnet St Ste 625 Houston, TX 77036

1-844 4PSODEX www.psodexusa.com

MANUFACTURED FOR

Yesim Derma Laboratories

Section 51945-4 (51945-4)

Purpose

Acne treatment

Warnings

For external use only

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
Do Not Use (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
Active Ingredient (Active ingredient)

Salicylic Acid 1.5%

Other Information (Other information)

Store at controlled room temperature 59-86°F

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

Questions Or Comments (Questions or Comments)

1 844 4PSODEX | [email protected]

When Using This Product (When using this product)

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

Ask A Doctor Before Use If (Ask a doctor before use if)

Condition covers a large area of the body

Stop Use and Ask A Doctor If (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 (Keep out of reach of children)

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


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