Ndc- 79903-139, Astringent Deep Cleaning

Ndc- 79903-139, Astringent Deep Cleaning
SPL v3
SPL
SPL Set ID e4e3226e-61f3-2264-e053-2a95a90a8e78
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
Benzophenone-4 Isoceteth-20 Alcohol Fragrance Clean Orc0600327 Fd&c Red No. 4 Water

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 form source of heat or fire
Indications and Usage

Use: For the treatment of acne

Description

Salicylic Acid

Pdp 03

Section 55105-1

Acne treatment

Section 55106-9

Salicylic Acid

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.

Other Information

Store at room temperature.

Inactive Ingredients

Water, Alcohol Denat, Isoceteth-20, Fragrance (Parfum), Benzophenone-4, Red 4

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.

Keep Out of Reach of Children.

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

Ask Doctor Or Pharmacist Before Use

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 03 (PDP 03)

Indications and Usage (34067-9)

Use: For the treatment of acne

Warnings and Precautions (34071-1)
  • For external use only.
  • Flammable
  • Keep away form source of heat or fire
Section 55105-1 (55105-1)

Acne treatment

Section 55106-9 (55106-9)

Salicylic Acid

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.

Other Information

Store at room temperature.

Inactive Ingredients

Water, Alcohol Denat, Isoceteth-20, Fragrance (Parfum), Benzophenone-4, Red 4

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.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask Doctor Or Pharmacist Before Use (Ask doctor or pharmacist before use)

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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