SPL v4
SPL
SPL Set ID 4baa8342-e983-43bb-9864-caf14bff21e3
Route
TOPICAL
Published
Effective Date 2021-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Water Alcohol Mandelic Acid Glycerin Purslane Butylene Glycol Phenoxyethanol Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-01

Description

Salicylic Acid 2%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Salicylic Acid 2%

Uses

• For the treatment of acne

• Helps prevent development of new acne blemishes

Warnings

For External Use Only

Do not use if you

• are pregnant

• are a child under 3 years of age

• are allergic to salicylates



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 one topical acne medication at a time.

• Avoid unnecessary sun exposure and use a sunscreen.

• Avoid contact with the eyes, lips and mouth.

• First time users may experience tingling sensation and visible peeling. After frequent usage, tingling and peeling will likely reduce.



Stop use and ask a doctor if

• Irritation becomes severe

Direction

• Cleanse the skin thoroughly before applying this product

• For treatment of acne, wet cotton bud or pad with solution and cover the entire affected area with a thin layer one to three times daily. Suitable for both facial and body acne.

• 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.

• Complement this with other Skinlycious products to reduce the likelihood of skin dryness.

• For full face exfoliant, wet cotton pad with a solution and apply a thin layer in the evening only over the entire face. No need to rinse off. Once skin condition improves, reduce frequency to no more than 3-5 times a week in the evening only.

Drug Facts

Product Label

Active Ingredient

Salicylic Acid 2%

Other Information

• Store in a cool dry place away from direct sun.

Inactive Ingredients

Water, Alcohol Denat. Mandelic Acid, Glycerin, Purslane, Butylene Glycol, Phenoxyethanol, Ethylhexylglycerin.

Questions Or Comments

(302) 291-7376

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 of acne

• Helps prevent development of new acne blemishes

Purpose

Acne treatment

Warnings

For External Use Only

Do not use if you

• are pregnant

• are a child under 3 years of age

• are allergic to salicylates



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 one topical acne medication at a time.

• Avoid unnecessary sun exposure and use a sunscreen.

• Avoid contact with the eyes, lips and mouth.

• First time users may experience tingling sensation and visible peeling. After frequent usage, tingling and peeling will likely reduce.



Stop use and ask a doctor if

• Irritation becomes severe

Direction

• Cleanse the skin thoroughly before applying this product

• For treatment of acne, wet cotton bud or pad with solution and cover the entire affected area with a thin layer one to three times daily. Suitable for both facial and body acne.

• 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.

• Complement this with other Skinlycious products to reduce the likelihood of skin dryness.

• For full face exfoliant, wet cotton pad with a solution and apply a thin layer in the evening only over the entire face. No need to rinse off. Once skin condition improves, reduce frequency to no more than 3-5 times a week in the evening only.

Drug Facts

Product Label (Product label)

Active Ingredient (Active ingredient)

Salicylic Acid 2%

Other Information (Other information)

• Store in a cool dry place away from direct sun.

Inactive Ingredients

Water, Alcohol Denat. Mandelic Acid, Glycerin, Purslane, Butylene Glycol, Phenoxyethanol, Ethylhexylglycerin.

Questions Or Comments (Questions or Comments)

(302) 291-7376

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

All Sections (JSON)