SPL v6
SPL
SPL Set ID d0f5c24d-fee2-4a0c-9018-082d9f1bd54b
Route
TOPICAL
Published
Effective Date 2013-02-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (1 g)
Inactive Ingredients
Water Glycolic Acid Propylene Glycol Azelaic Acid Hamamelis Virginiana Root Bark/stem Bark Deanol Phenoxyethanol Sodium Hydroxide Camellia Sinensis Whole Hydrogenated Polydecene (550 Mw) Trideceth-6 Filipendula Ulmaria Flower Licorice Ocimum Basilicum Flowering Top Passiflora Edulis Flower Aloe Vera Leaf Salvia Officinalis Flowering Top

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-02-07

Description

PURPOSE ACNE TREATMENT


Medication Information

Warnings and Precautions

WARNINGS FOR EXTERNAL USE ONLY

Indications and Usage

USE

FOR THE TREATMENT OF ACNE

Dosage and Administration

Directions

Gently apply a small amount of Clearing Tonic to affected area using your bare hands. Avoid contact with eyes.

  • Cleanse the skin thoroughly before applying medication
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Description

PURPOSE ACNE TREATMENT

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product avoid contact with eyes. If contact occurs, flush thoroughly with water.

Section 50568-5

Ask a 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 directed by a doctor.

Section 51727-6

Inactive Ingredients

Water, glycolic acid, propylene glycol, azelaic acid, hamamelis virginiana (witch hazel) distillate, dimethylethanolamine, phenoxyethanol, sodium hydroxide, camellia sinensis (green tea) leaf extract, passiflora edulis (passion) flower extract, aloe barbadensis leaf extract, salvia officinalis (sage) leaf extract, fragrance.

Section 51945-4

Section 53413-1

Questions? 1-866-404-7656 or www.exposedskincare.com

Section 55105-1

PURPOSE

ACNE TREATMENT

Section 55106-9

ACTIVE INGREDIENT

SALICYLIC ACID (1%)


Structured Label Content

Indications and Usage (34067-9)

USE

FOR THE TREATMENT OF ACNE

Dosage and Administration (34068-7)

Directions

Gently apply a small amount of Clearing Tonic to affected area using your bare hands. Avoid contact with eyes.

  • Cleanse the skin thoroughly before applying medication
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Warnings and Precautions (34071-1)

WARNINGS FOR EXTERNAL USE ONLY

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes. If contact occurs, flush thoroughly with water.

Section 50568-5 (50568-5)

Ask a 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 directed by a doctor.

Section 51727-6 (51727-6)

Inactive Ingredients

Water, glycolic acid, propylene glycol, azelaic acid, hamamelis virginiana (witch hazel) distillate, dimethylethanolamine, phenoxyethanol, sodium hydroxide, camellia sinensis (green tea) leaf extract, passiflora edulis (passion) flower extract, aloe barbadensis leaf extract, salvia officinalis (sage) leaf extract, fragrance.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? 1-866-404-7656 or www.exposedskincare.com

Section 55105-1 (55105-1)

PURPOSE

ACNE TREATMENT

Section 55106-9 (55106-9)

ACTIVE INGREDIENT

SALICYLIC ACID (1%)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)