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SPL v1

SPL

SPL Set ID 46623a3e-37bf-3ee4-e063-6294a90ae60d

Routes

PERCUTANEOUS EXTRACORPOREAL CUTANEOUS

Published

Effective Date 2025-12-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Salicylic Acid (1.4 g)

Inactive Ingredients

Barosma Betulina Leaf Oil Icodextrin Niacinamide Madecassoside Hydroxyacetophenone Zea Mays (corn) Starch Xanthan Gum 1,2-hexanediol Asiaticoside Centella Asiatica Whole Pentylene Glycol Aqua Purslane Citric Acid Butylene Glycol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-12-21

Description

SALICYLIC ACID 1.4%

Purpose

Clear acne and breakouts

Medication Information

Purpose

Clear acne and breakouts

Dosage and Administration

Apply an appropriate amount evenly to face and neck after cleansing

Description

SALICYLIC ACID 1.4%

Uses

* Clear acne and breakouts

* Moisturize and soothing

* Strengthen skin barrier

Section 50565-1

Keep out of reach of children.

Section 51945-4

Warnings

For external uses only Do not use on damaged or broken skin

Avoid eye contact when using, if contact occurs, rinse with water to remove

Stop use if rash and irritation occur Keep out of reach of children.

Directions

Apply an appropriate amount evenly to face and neck after cleansing

Active Ingredient

SALICYLIC ACID 1.4%

Inactive Ingredients

AQUA、

BUTYLENE GLYCOL、

NIACINAMIDE、

ZEA MAYS (CORN) STARCH、

ICODEXTRIN、

XANTHAN GUM、

1,2-HEXANEDIOL、

PENTYLENE GLYCOL、

YDROXYACETOPHENONE、

MADECASSOSIDE、

BAROSMA BETULINA LEAF OIL、

PURSLANE、

CENTELLA ASIATICA WHOLE、

ASIATICOSIDE、

CITRIC ACID

Structured Label Content

Uses

* Clear acne and breakouts

* Moisturize and soothing

* Strengthen skin barrier

Dosage and Administration (34068-7)

Apply an appropriate amount evenly to face and neck after cleansing

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Purpose

Clear acne and breakouts

Warnings

For external uses only Do not use on damaged or broken skin

Avoid eye contact when using, if contact occurs, rinse with water to remove

Stop use if rash and irritation occur Keep out of reach of children.

Directions

Apply an appropriate amount evenly to face and neck after cleansing

Active Ingredient

SALICYLIC ACID 1.4%

Inactive Ingredients

AQUA、

BUTYLENE GLYCOL、

NIACINAMIDE、

ZEA MAYS (CORN) STARCH、

ICODEXTRIN、

XANTHAN GUM、

1,2-HEXANEDIOL、

PENTYLENE GLYCOL、

YDROXYACETOPHENONE、

MADECASSOSIDE、

BAROSMA BETULINA LEAF OIL、

PURSLANE、

CENTELLA ASIATICA WHOLE、

ASIATICOSIDE、

CITRIC ACID

Advanced Ingredient Data

[{"name": "BAROSMA BETULINA LEAF OIL", "unii": "KOS935A04V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ICODEXTRIN", "unii": "2NX48Z0A9G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NIACINAMIDE", "unii": "25X51I8RD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MADECASSOSIDE", "unii": "CQ2F5O6YIY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYACETOPHENONE", "unii": "G1L3HT4CMH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "1.4", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "ZEA MAYS (CORN) STARCH", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "1,2-HEXANEDIOL", "unii": "TR046Y3K1G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ASIATICOSIDE", "unii": "PKO39VY215", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CENTELLA ASIATICA WHOLE", "unii": "7M867G6T1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PENTYLENE GLYCOL", "unii": "50C1307PZG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AQUA", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PURSLANE", "unii": "M6S840WXG5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLENE GLYCOL", "unii": "3XUS85K0RA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "* Clear acne and breakouts * Moisturize and soothing * Strengthen skin barrier", "34068-7": "Apply an appropriate amount evenly to face and neck after cleansing", "50565-1": "Keep out of reach of children.", "Purpose": "Clear acne and breakouts", "Warnings": "For external uses only Do not use on damaged or broken skin Avoid eye contact when using, if contact occurs, rinse with water to remove Stop use if rash and irritation occur Keep out of reach of children.", "Directions": "Apply an appropriate amount evenly to face and neck after cleansing", "Active Ingredient": "SALICYLIC ACID 1.4%", "Inactive Ingredients": "AQUA、 BUTYLENE GLYCOL、 NIACINAMIDE、 ZEA MAYS (CORN) STARCH、 ICODEXTRIN、 XANTHAN GUM、 1,2-HEXANEDIOL、 PENTYLENE GLYCOL、 YDROXYACETOPHENONE、 MADECASSOSIDE、 BAROSMA BETULINA LEAF OIL、 PURSLANE、 CENTELLA ASIATICA WHOLE、 ASIATICOSIDE、 CITRIC ACID"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:51.469123 · Updated: 2026-03-14T23:11:47.306350