27f19c03-1a18-6c74-e063-6394a90a6e86

SPL v2
SPL
SPL Set ID 27f19c03-1a18-6c74-e063-6394a90a6e86
Route
topical
Published
Effective Date 2024-12-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (0.5 mg)
Inactive Ingredients
glycerin

Identifiers & Packaging

Pill Appearance
Imprint: 1 Shape: pentagon (5 sided) Color: white Size: 30 mm
Marketing Status
otc monograph drug active Since 2025-01-15

Description

Active Ingredient: Salicylic Acid 0.5%.


Medication Information

Indications and Usage

Helps exfoliate and renew skin for a smoother, brighter appearance. Hydrates and improves skin texture.

Dosage and Administration

1. Cleanse face thoroughly. 2. Apply the mask to dry skin, avoiding contact with eyes. 3. Leave on for 15-20 minutes andremove gently. 4. Use once or twice a week as needed.

Description

Active Ingredient: Salicylic Acid 0.5%.

Dosage

Apply a thin, even layer to clean, dry skin. Leave on for 10–15 minutes. Rinse thoroughly with warm water. Use 1–2 times per week or as directed by a healthcare provider."

Section 50565-1

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

Section 51727-6

Water, Glycerin, Aloe Vera Leaf Juice, Lactic Acid, Glycolic Acid, Kaolin, Citric Acid, Fragrance.

Section 51945-4

See attached image for the Principal Display Panel.

Section 55105-1

Exfoliation and skin renewal.

Warning Section

For external use only. Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if rash or irritation occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient(s)

Active Ingredient: Salicylic Acid 0.5%.


Structured Label Content

Indications and Usage (34067-9)

Helps exfoliate and renew skin for a smoother, brighter appearance. Hydrates and improves skin texture.

Dosage and Administration (34068-7)

1. Cleanse face thoroughly. 2. Apply the mask to dry skin, avoiding contact with eyes. 3. Leave on for 15-20 minutes andremove gently. 4. Use once or twice a week as needed.

Dosage

Apply a thin, even layer to clean, dry skin. Leave on for 10–15 minutes. Rinse thoroughly with warm water. Use 1–2 times per week or as directed by a healthcare provider."

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 51727-6 (51727-6)

Water, Glycerin, Aloe Vera Leaf Juice, Lactic Acid, Glycolic Acid, Kaolin, Citric Acid, Fragrance.

Section 51945-4 (51945-4)

See attached image for the Principal Display Panel.

Section 55105-1 (55105-1)

Exfoliation and skin renewal.

Warning Section

For external use only. Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if rash or irritation occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient(s)

Active Ingredient: Salicylic Acid 0.5%.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)