SPL v1
SPL
SPL Set ID 21cedce7-61e0-6479-e063-6294a90abf5d
Route
TOPICAL
Published
Effective Date 2024-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Xanthan Gum Cinnamon Bark Oil Glycerin Capryloyl Glycine Ppg-2 Isoceteth-20 Acetate Cedrus Atlantica Bark Propylene Glycol Laureth-7 Phenoxyethanol Cyclomethicone 5 Butylene Glycol Alcohol Phenyl Trimethicone Polysorbate 20 C12-15 Alkyl Lactate Sarcosine C13-14 Isoparaffin Hamamelis Virginiana Leaf Edetate Disodium Water Polyacrylamide (crosslinked; 2 Mole Percent Bisacrylamide) Myristamidopropyl Pg-dimonium Chloride Phosphate Cetyl Lactate Benzalkonium Chloride Purslane

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-02

Description

Salicylic Acid 2%

Purpose

Acne Medication


Medication Information

Purpose



Acne Medication

Description

Salicylic Acid 2%

Use



For the treatment of acne

Label

Warnings



When using this product

skin irritation and dryness is more likely to occur if you use another topical cene medication at the same time. If irritation occurs, only use one topical

acne medication at a time.

Directions



Clean the skin thoroughly before applying this product.

Cover the entire affected area with a thin layer one to three times daily.

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

directed by a doctor.

If some drynesss or peeling occurs, reduce application to once a day or every other day.

If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Active Ingredient



Salicylic Acid 2%

Do Not Use If You



Do not use if you have very sentitive skin.

Other Information



Store at 20°C-25°C (68°F-77°F)

Inactive Gredients



Water

Alcohol

Phenyl Trimethicone

C13-14 Isoparaffin

Laureth-7

Polyacrylamide

Glycerin

Hamamelis Virginiana (Witch Hazel) Exact

Polysorbate 20

Phenoxyethanol

Propylene Glycol

Xanthan Gum

Fragrance

Cyclopentasiloxane

C12-15 Alkyl Lactate

Cetyl Lactate,

PPG-2 Isoceteth-20 Acetate

Myristamidopropyl PG-dimonium Chloride Phosphate

Benzalkonium Chloride,

Disodium EDTA,

Butylene Glycol,

Capryloyl Glycine,

Sarcosine

Cinnamomum Zeylanicum Bark Extract,

Cedrus Atantica Bark Extract,

Portulaca Oleracea Extact

When Using This Product



avoid unnessary sun exposure and use sunscreen.

avoid contact with eyes, lips, and mouth.

avoid contact with hair and dyed fabrics, which may be bleached by this product.

skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less

frequently or a lower concentration.

Stop Use and Ask A Doctor If



irritation becomes severer.

Keep Out of Reach of Children



If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use



For the treatment of acne

Label

Purpose



Acne Medication

Warnings



When using this product

skin irritation and dryness is more likely to occur if you use another topical cene medication at the same time. If irritation occurs, only use one topical

acne medication at a time.

Directions



Clean the skin thoroughly before applying this product.

Cover the entire affected area with a thin layer one to three times daily.

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

directed by a doctor.

If some drynesss or peeling occurs, reduce application to once a day or every other day.

If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Active Ingredient (Active ingredient)



Salicylic Acid 2%

Do Not Use If You (Do not use if you)



Do not use if you have very sentitive skin.

Other Information (Other information)



Store at 20°C-25°C (68°F-77°F)

Inactive Gredients (Inactive gredients)



Water

Alcohol

Phenyl Trimethicone

C13-14 Isoparaffin

Laureth-7

Polyacrylamide

Glycerin

Hamamelis Virginiana (Witch Hazel) Exact

Polysorbate 20

Phenoxyethanol

Propylene Glycol

Xanthan Gum

Fragrance

Cyclopentasiloxane

C12-15 Alkyl Lactate

Cetyl Lactate,

PPG-2 Isoceteth-20 Acetate

Myristamidopropyl PG-dimonium Chloride Phosphate

Benzalkonium Chloride,

Disodium EDTA,

Butylene Glycol,

Capryloyl Glycine,

Sarcosine

Cinnamomum Zeylanicum Bark Extract,

Cedrus Atantica Bark Extract,

Portulaca Oleracea Extact

When Using This Product (When using this product)



avoid unnessary sun exposure and use sunscreen.

avoid contact with eyes, lips, and mouth.

avoid contact with hair and dyed fabrics, which may be bleached by this product.

skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less

frequently or a lower concentration.

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



irritation becomes severer.

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



If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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