Oil Free Acne Wash

Oil Free Acne Wash
SPL v2
SPL
SPL Set ID e4ccc482-3258-ec0d-e053-2a95a90a9ceb
Route
TOPICAL
Published
Effective Date 2022-07-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2000 mg)
Inactive Ingredients
Fd&c Red No. 40 Fragrance Clean Orc0600327 Water Matricaria Chamomilla Flowering Top Basic Yellow 5 Edetate Disodium Cocamidopropyl Pg-dimonium Chloride Phosphate Aloe Vera Leaf Sodium Hydroxide Peg-80 Sorbitan Laurate C12-15 Alkyl Lactate Benzalkonium Chloride Citric Acid Monohydrate Sodium C14-16 Olefin Sulfonate Cocamidopropyl Betaine Sodium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-19

Description

Salicylic Acid


Medication Information

Warnings and Precautions

For external use only:

  • Flammable
  • keep away from source of heat or Fire
Description

Salicylic Acid

Pdp 01

Pdp 02

Section 50565-1

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Section 55105-1

Acne treatment

Directions

New Users: Apply to small area before use to test for sensitivity. If no discomfort occurs, apply to affected area and rinse off. Start with one application and gradually increase to 2-3 times daily if needed or as directed by physician.

Active Ingredient

Salicylic Acid

Other Information
  • Store at room temperature.
Inactive Ingredients

Water (Aqua), Soduum C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Sodium Chloride, PEG-80 Sorbitan Laurate, Citric Acid, , Disodium EDTA, C12-15 Alkyl Lactate, Benzolkonium Chloride, Fragrance ( Parfum), Cocamidopropyl PG-Dimonium Chloride Phosphate, Aloe Barbadensis, Leaf Extract, Chamomilla Recutita(Matricaria) Flower Extract, Sodium Hydroxide , Yellow 5, Red 40

Indication and Usage

To be used to treat pimples (acne)..

When Using This Product

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water for 15 minutes.

Stop Use and Ask A Doctor

Stop use and ask a doctor if irritation, dryness or redness develops and lasts. Ask doctor before use if pregnant/breastfeeding.

Ask Doctor Or Pharmacist Before Use If You Are

Ask doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of

this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless otherwise directed by a doctor.


Structured Label Content

Pdp 01 (PDP-01)

Pdp 02 (PDP-02)

Warnings and Precautions (34071-1)

For external use only:

  • Flammable
  • keep away from source of heat or Fire
Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Section 55105-1 (55105-1)

Acne treatment

Directions

New Users: Apply to small area before use to test for sensitivity. If no discomfort occurs, apply to affected area and rinse off. Start with one application and gradually increase to 2-3 times daily if needed or as directed by physician.

Active Ingredient

Salicylic Acid

Other Information
  • Store at room temperature.
Inactive Ingredients (Inactive ingredients)

Water (Aqua), Soduum C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Sodium Chloride, PEG-80 Sorbitan Laurate, Citric Acid, , Disodium EDTA, C12-15 Alkyl Lactate, Benzolkonium Chloride, Fragrance ( Parfum), Cocamidopropyl PG-Dimonium Chloride Phosphate, Aloe Barbadensis, Leaf Extract, Chamomilla Recutita(Matricaria) Flower Extract, Sodium Hydroxide , Yellow 5, Red 40

Indication and Usage

To be used to treat pimples (acne)..

When Using This Product (When using this product)

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water for 15 minutes.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

Stop use and ask a doctor if irritation, dryness or redness develops and lasts. Ask doctor before use if pregnant/breastfeeding.

Ask Doctor Or Pharmacist Before Use If You Are (Ask doctor or pharmacist before use if you are)

Ask doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of

this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless otherwise directed by a doctor.


Advanced Ingredient Data


Raw Label Data

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