SPL v1
SPL
SPL Set ID 24bf6f8c-d4ba-2581-e063-6394a90a868d
Route
TOPICAL
Published
Effective Date 2024-10-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (1 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-18

Description

Salicylic Acid

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Salicylic Acid

Use

for the treatment of acne

Section 51945-4

Warnings

For external use only

Do Not Use

Do not use this if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

Active Ingredient

Salicylic Acid

Other Information

Keep tightly closed.Avoid storing at extreme temperatures (below 40° fand above 100° F).

Inactive Ingredients

Tea Tree Oil,Calendula,Cica Oil,Castor Oil,Argan Oil

Dosage & Administration

stick on acne

Directions of Safe Use:

Cleanse skin thoroughly before appying Acne patch. Cover the enire afected

area with a thin layer 1-3 times daiy. lf bothersome dryness or peeing occurs, reduce application to once a day.

When Using This Product

keep away from eyes, lips and mouth

wavoid unnecessary sun exposure and use a sunscreen

avoid contact with hair or dyed fabric, including carpet and clothing which may be bleached by this product

skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly

swelling. Mild irritation may be reduced by using the product less frequenty or in a lower concentration.

Ifirritation becomes severe,discontinue use; ifirritation still continues, consulta doctor

wusing other topical acne medication at the same time or immediately following the use of this product may

increase dryness or iritation of the skin, lf this occurs, only one medication should be used unless directed

by a doctor.

Keep Out of Reach of Children

Keep out of reach of children.tfswallowed, get help or contact

a Poison Control Center right away.Avoid contact with the eyes. lf contact occurs,flush thoroughly with water.


Structured Label Content

Use

for the treatment of acne

Section 51945-4 (51945-4)

Purpose

Acne Treatment

Warnings

For external use only

Do Not Use (Do not use)

Do not use this if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

Active Ingredient (ACTIVE INGREDIENT)

Salicylic Acid

Other Information (Other information)

Keep tightly closed.Avoid storing at extreme temperatures (below 40° fand above 100° F).

Inactive Ingredients (Inactive ingredients)

Tea Tree Oil,Calendula,Cica Oil,Castor Oil,Argan Oil

Dosage & Administration (DOSAGE & ADMINISTRATION)

stick on acne

Directions of Safe Use: (Directions Of Safe Use:)

Cleanse skin thoroughly before appying Acne patch. Cover the enire afected

area with a thin layer 1-3 times daiy. lf bothersome dryness or peeing occurs, reduce application to once a day.

When Using This Product (When using this product)

keep away from eyes, lips and mouth

wavoid unnecessary sun exposure and use a sunscreen

avoid contact with hair or dyed fabric, including carpet and clothing which may be bleached by this product

skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly

swelling. Mild irritation may be reduced by using the product less frequenty or in a lower concentration.

Ifirritation becomes severe,discontinue use; ifirritation still continues, consulta doctor

wusing other topical acne medication at the same time or immediately following the use of this product may

increase dryness or iritation of the skin, lf this occurs, only one medication should be used unless directed

by a doctor.

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

Keep out of reach of children.tfswallowed, get help or contact

a Poison Control Center right away.Avoid contact with the eyes. lf contact occurs,flush thoroughly with water.


Advanced Ingredient Data


Raw Label Data

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