46623a3e-37bf-3ee4-e063-6294a90ae60d

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

Purpose

Clear acne and breakouts

Description

SALICYLIC ACID 1.4%


Medication Information

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.

Uses

* Clear acne and breakouts

* Moisturize and soothing

* Strengthen skin barrier

Purpose

Clear acne and breakouts

Dosage and Administration

Apply an appropriate amount evenly to face and neck after cleansing

Directions

Apply an appropriate amount evenly to face and neck after cleansing

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

Description

SALICYLIC ACID 1.4%

Section 50565-1

Keep out of reach of children.

Section 51945-4

Active Ingredient

SALICYLIC ACID 1.4%


Structured Label Content

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.

Uses

* Clear acne and breakouts

* Moisturize and soothing

* Strengthen skin barrier

Purpose

Clear acne and breakouts

Dosage and Administration (34068-7)

Apply an appropriate amount evenly to face and neck after cleansing

Directions

Apply an appropriate amount evenly to face and neck after cleansing

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Active Ingredient

SALICYLIC ACID 1.4%


Advanced Ingredient Data


Raw Label Data

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