Salicylic Serum 1%

Salicylic Serum 1%
SPL v3
SPL
SPL Set ID 8d2f7114-6a6f-cc15-e053-2995a90a4689
Route
TOPICAL
Published
Effective Date 2019-06-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (1 g)
Inactive Ingredients
Butylene Glycol Diethylene Glycol Monoethyl Ether Saccharide Isomerate Sodium Lactate Sodium Alginate Zinc Sulfate Lactic Acid Potassium Hydroxide Xanthan Gum Glycolic Acid Magnesium Aluminum Silicate Anhydrous Citric Acid Water Alcohol Witch Hazel Hydroxyethyl Cellulose (100 Mpa.s At 2%)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-05-10

Description

SALICYLIC ACID 1%

Purpose

TREATMENT OF ACNE


Medication Information

Purpose

TREATMENT OF ACNE

Description

SALICYLIC ACID 1%

Use

For the treatment of acne.

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if irritation or sensitivity develops.

Section 51945-4

Warnings

For External Use Only,

When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.

If irritation occurs, only use 1 topical acne medication at a time.

• Avoid unnecessary sun exposure and use a sunscreen.

Directions

Important to use on a clean face. Cover affected area with a thin layer 1 to 3 times per day. Due to excessive drying of the skin may occur, start with 1 application per day then gradually increase to 2 applications per day, one morning and one evening if needed, or as directed by a doctor. If dryness or peeling occurs, reduce use to once a day or once every other day. If going outside, use a sunscreen. If irritation or sensitivity develops stop using both products and ask a doctor.

Questions?

Call toll-free T 1-800-200-6365

or visit www.acneintelligence.com

Active Ingredient

SALICYLIC ACID 1%

Other Information

Keep tightly closed.

Protect from excessive heat (40°/140°F) and protect from freezing.

Inactive Ingredients

Water (Aqua), SD Alcohol 40-B, Butylene Glycol, Ethoxydiglycol, Hamamelis Virginiana (Witch Hazel) Water, Saccharide lsomerate, Sodium Lactate, Hydrolyzed Algin, Zinc Sulfate, Glycolic Acid, Lactic Acid, Hydroxyethylcellulose, Potassium Hydroxide, Magnesium Aluminum Silicate, Citric Acid, Xanthan Gum, Fragrance (Parfum)


Structured Label Content

Use (USE)

For the treatment of acne.

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 50566-9 (50566-9)

Stop use and ask a doctor if irritation or sensitivity develops.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

TREATMENT OF ACNE

Warnings (WARNINGS)

For External Use Only,

When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.

If irritation occurs, only use 1 topical acne medication at a time.

• Avoid unnecessary sun exposure and use a sunscreen.

Directions (DIRECTIONS)

Important to use on a clean face. Cover affected area with a thin layer 1 to 3 times per day. Due to excessive drying of the skin may occur, start with 1 application per day then gradually increase to 2 applications per day, one morning and one evening if needed, or as directed by a doctor. If dryness or peeling occurs, reduce use to once a day or once every other day. If going outside, use a sunscreen. If irritation or sensitivity develops stop using both products and ask a doctor.

Questions? (QUESTIONS?)

Call toll-free T 1-800-200-6365

or visit www.acneintelligence.com

Active Ingredient (ACTIVE INGREDIENT)

SALICYLIC ACID 1%

Other Information (OTHER INFORMATION)

Keep tightly closed.

Protect from excessive heat (40°/140°F) and protect from freezing.

Inactive Ingredients (INACTIVE INGREDIENTS)

Water (Aqua), SD Alcohol 40-B, Butylene Glycol, Ethoxydiglycol, Hamamelis Virginiana (Witch Hazel) Water, Saccharide lsomerate, Sodium Lactate, Hydrolyzed Algin, Zinc Sulfate, Glycolic Acid, Lactic Acid, Hydroxyethylcellulose, Potassium Hydroxide, Magnesium Aluminum Silicate, Citric Acid, Xanthan Gum, Fragrance (Parfum)


Advanced Ingredient Data


Raw Label Data

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