SPL v7
SPL
SPL Set ID 9338556d-4afe-40be-91cc-2d8f3bf5d54e
Route
TOPICAL
Published
Effective Date 2013-03-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (1 g)
Inactive Ingredients
Water Hamamelis Virginiana Root Bark/stem Bark Glycerin Propylene Glycol Peg-120 Methyl Glucose Dioleate Polyquaternium-37 (10000 Mpa.s) Hydrogenated Polydecene (550 Mw) Trideceth-6 Filipendula Ulmaria Flower Licorice Ocimum Basilicum Flowering Top Camellia Sinensis Whole Panthenol Phenoxyethanol

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 serum 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, hamamelis virginiana (witch hazel) distillate, glycerin, propylene glycol, peg 120 methyl glucose dioleate, polyquaternium-37, hydrogenated polydecene, tricedeth-6, spiraea ulmaria (meadowsweet) extract, glycyrrhiza glabra (licorice) root extract, ocimum basilicum extract , camellia sinensis (green tea) leaf extract, panthenol, phenoxyethanol, fragrance.

Section 51945-4

Section 53413-1

Questions? 1-866-404-7656

Section 55105-1

PURPOSE

ACNE TREATMENT

Section 55106-9

ACTIVE INGREDIENT

SALICYLIC ACID (1.0%)


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 serum 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, hamamelis virginiana (witch hazel) distillate, glycerin, propylene glycol, peg 120 methyl glucose dioleate, polyquaternium-37, hydrogenated polydecene, tricedeth-6, spiraea ulmaria (meadowsweet) extract, glycyrrhiza glabra (licorice) root extract, ocimum basilicum extract , camellia sinensis (green tea) leaf extract, panthenol, phenoxyethanol, fragrance.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? 1-866-404-7656

Section 55105-1 (55105-1)

PURPOSE

ACNE TREATMENT

Section 55106-9 (55106-9)

ACTIVE INGREDIENT

SALICYLIC ACID (1.0%)


Advanced Ingredient Data


Raw Label Data

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