SPL v2
SPL
SPL Set ID 1b2f4718-b174-9b50-e063-6394a90ac2f4
Route
TOPICAL
Published
Effective Date 2024-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (5 mg)
Inactive Ingredients
Coco Monoethanolamide Sodium Hydroxide Sodium Hypochlorite Edetate Disodium Water Propanediol Cocamidopropyl Betaine Peg-120 Methyl Glucose Dioleate Sodium Laureth Sulfate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-09-01

Description

Salicylic Acid 0.5%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Salicylic Acid 0.5%

Uses

For the treatment of acne

Section 51945-4

Warnings

For external use only.

Directions

Cleanse twice daily or as indicated by your physician. Treat whole area. Wet the skin. Dispense into wet hands. Massage area gently for 30 seconds working to create a lather. Rinse thoroughly with warm water. If bothersome dryness or peeling occurs, reduce use to once a day or every other day.

Active Ingredients

Salicylic Acid 0.5%

Inactive Ingredients

Purified Water (Aqua), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide MEA, PEG-120 Methyl Glucose Trioleate, Propanediol, Sodium Hypochlorite, Disodium EDTA, Sodium Hydroxide.

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 Contact With Eyes.

If contact occurs, flush thoroughly with water

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

Section 51945-4 (51945-4)

Purpose

Acne Treatment

Warnings

For external use only.

Directions

Cleanse twice daily or as indicated by your physician. Treat whole area. Wet the skin. Dispense into wet hands. Massage area gently for 30 seconds working to create a lather. Rinse thoroughly with warm water. If bothersome dryness or peeling occurs, reduce use to once a day or every other day.

Active Ingredients

Salicylic Acid 0.5%

Inactive Ingredients

Purified Water (Aqua), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide MEA, PEG-120 Methyl Glucose Trioleate, Propanediol, Sodium Hypochlorite, Disodium EDTA, Sodium Hydroxide.

When Using This Product (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 Contact With Eyes. (Avoid contact with eyes.)

If contact occurs, flush thoroughly with water

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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