acne buster *140

SPL v1

SPL

SPL Set ID 3876df38-0085-ce8f-e063-6294a90a83ac

Route

transdermal

Published

Effective Date 2025-06-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

salicylic acid (5 mg)

Inactive Ingredients

polyisobutylene (1000 mw) aloe barbadensis leaf carboxymethylcellulose sodium melaleuca alternifolia (tea tree) leaf oil guar gum

Identifiers & Packaging

Marketing Status

unapproved drug other active Since 2025-06-26

Purpose

Acne treatment

Description

Salicylic Acid, 0.5%. Purpose: Acne treatment

Medication Information

Warnings

For external use only.

Uses

Soothe and help diminish the redness and irritation of blemished skin & absorbs excess oil for faster healing.

Purpose

Acne treatment

Directions

Cleanse and dry face, removing any makeup.

Apply one healing dot, sticky side down, over your blemish.

Leave the healing dot over blemish for at least 6 hours or overnight.

Repeat as necessary with a new healing dot.

Inactive Ingredients

Cellulose Gum, Guar Gum, Polyisobutene, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aloe Barbadensis Leaf Extract.

Description

Salicylic Acid, 0.5%. Purpose: Acne treatment

Section 50565-1

Keep out of reach of children.

Active Ingredient

Salicylic Acid, 0.5%. Purpose: Acne treatment

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.

Package Label Principal Display Panel

Structured Label Content

Warnings

For external use only.

Uses

Soothe and help diminish the redness and irritation of blemished skin & absorbs excess oil for faster healing.

Purpose

Acne treatment

Directions

Cleanse and dry face, removing any makeup.

Apply one healing dot, sticky side down, over your blemish.

Leave the healing dot over blemish for at least 6 hours or overnight.

Repeat as necessary with a new healing dot.

Inactive Ingredients (Inactive ingredients)

Cellulose Gum, Guar Gum, Polyisobutene, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aloe Barbadensis Leaf Extract.

Section 50565-1 (50565-1)

Keep out of reach of children.

Active Ingredient (Active ingredient)

Salicylic Acid, 0.5%. Purpose: Acne treatment

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.

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Advanced Ingredient Data

[{"name": "POLYISOBUTYLENE (1000 MW)", "unii": "5XB3A63Y52", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE BARBADENSIS LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL", "unii": "VIF565UC2G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GUAR GUM", "unii": "E89I1637KE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Soothe and help diminish the redness and irritation of blemished skin & absorbs excess oil for faster healing.", "50565-1": "Keep out of reach of children.", "Purpose": "Acne treatment", "Warnings": "For external use only.", "Directions": "Cleanse and dry face, removing any makeup. Apply one healing dot, sticky side down, over your blemish. Leave the healing dot over blemish for at least 6 hours or overnight. Repeat as necessary with a new healing dot.", "Active ingredient": "Salicylic Acid, 0.5%. Purpose: Acne treatment", "Inactive ingredients": "Cellulose Gum, Guar Gum, Polyisobutene, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aloe Barbadensis Leaf Extract.", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:23.671383 · Updated: 2026-03-14T23:09:09.169888