Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID ca1df191-1ef8-4dea-9458-0187f15daef7
Route
TOPICAL
Published
Effective Date 2017-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.5 g)
Inactive Ingredients
Water Sodium Hydride Lactic Acid Glycolic Acid Gluconolactone Propanediol Magnesium Chloride Glycereth-7 Trimethyl Ether Niacinamide Betaine Inositol Pentylene Glycol Peg-60 Hydrogenated Castor Oil Caprylyl Glycol Ethylhexylglycerin Acetic Acid Potassium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-11-30

Description

Salicylic Acid 0.5%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Salicylic Acid 0.5%

Uses

• for the treatment/management of acne

• penetrates pores to reduce acne

• helps prevent new acne from forming

Warnings

For external use only

When using this product

• avoid contact with the eyes

• if contact occurs, rinse thoroughly with water

• skin irritation and dryness are more likely to occur when

using another topical acne product at the same time. If irritation

occurs, use only one product at a time

Stop use and ask a doctor

• if you develop severe irritation, burning, or itching of the skin

• for more severe cases, and/or if improvement is not

apparent within 6-8 weeks, consult a health care professional

• if you develop hives, swelling of eyes and mouth, blistering,

or dif culty breathing, get medical help right away

Sunburn Alert: This product contains an alpha hydroxy acid

(AHA) that may increase your skin’s sensitivity to the sun and

particularly the possibility of sunburn. Use a sunscreen, wear

protective clothing, and limit sun exposure while using this

product and for a week afterwards.

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 as directed by a doctor

• if bothersome dryness or peeling occurs, reduce application

to once a day or every other day

Other Information

Protect this product in this container from

excessive heat and direct sun.

Active Ingredients

Salicylic Acid 0.5%

Inactive Ingredients

Aqua/Water/Eau, Sodium Hydroxide, Lactic Acid, Glycolic

Acid, Gluconolactone, Propanediol, Ethoxydiglycol, Magnesium

Chloride, Glycereth-7 Trimethyl Ether, Niacinamide, Betaine,

Inositol, Citric Acid, Glycerin, Phytic Acid, Pentylene

Glycol, PEG-60 Hydrogenated Castor Oil, Caprylyl Glycol,

Ethylhexylglycerin, Parfum/Fragrance, PEG-8, Aloe Barbadensis

Leaf Juice, Acetic Acid, Potassium Hydroxide.

Questions Or Comments?

visit Glossier.com, email us at [email protected], or call

toll-free 1-844-654-8326

Principal Display Panel

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.


Structured Label Content

Uses

• for the treatment/management of acne

• penetrates pores to reduce acne

• helps prevent new acne from forming

Purpose

Acne Treatment

Warnings

For external use only

When using this product

• avoid contact with the eyes

• if contact occurs, rinse thoroughly with water

• skin irritation and dryness are more likely to occur when

using another topical acne product at the same time. If irritation

occurs, use only one product at a time

Stop use and ask a doctor

• if you develop severe irritation, burning, or itching of the skin

• for more severe cases, and/or if improvement is not

apparent within 6-8 weeks, consult a health care professional

• if you develop hives, swelling of eyes and mouth, blistering,

or dif culty breathing, get medical help right away

Sunburn Alert: This product contains an alpha hydroxy acid

(AHA) that may increase your skin’s sensitivity to the sun and

particularly the possibility of sunburn. Use a sunscreen, wear

protective clothing, and limit sun exposure while using this

product and for a week afterwards.

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 as directed by a doctor

• if bothersome dryness or peeling occurs, reduce application

to once a day or every other day

Other Information

Protect this product in this container from

excessive heat and direct sun.

Active Ingredients

Salicylic Acid 0.5%

Inactive Ingredients

Aqua/Water/Eau, Sodium Hydroxide, Lactic Acid, Glycolic

Acid, Gluconolactone, Propanediol, Ethoxydiglycol, Magnesium

Chloride, Glycereth-7 Trimethyl Ether, Niacinamide, Betaine,

Inositol, Citric Acid, Glycerin, Phytic Acid, Pentylene

Glycol, PEG-60 Hydrogenated Castor Oil, Caprylyl Glycol,

Ethylhexylglycerin, Parfum/Fragrance, PEG-8, Aloe Barbadensis

Leaf Juice, Acetic Acid, Potassium Hydroxide.

Questions Or Comments? (Questions or comments?)

visit Glossier.com, email us at [email protected], or call

toll-free 1-844-654-8326

Principal Display Panel

Keep Out of Reach of Children (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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