Scar Treatment Balm

SPL v3

SPL

SPL Set ID 2cdc76f9-0044-fd07-e063-6294a90a680e

Route

TOPICAL

Published

Effective Date 2025-01-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Allantoin, (r)- (0.5 g)

Inactive Ingredients

Butyrospermum Parkii (shea) Butter Copernicia Cerifera (carnauba) Wax Silica Helianthus Annuus (sunflower) Seed Oil Ethylhexylglycerin Olea Europaea (olive) Fruit Oil Theobroma Cacao (cocoa) Seed Butter

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-01-15

Description

Allantoin 0.5%

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

Allantoin 0.5%

Uses

temporarily protects minor:  cuts  scrapes

 burns

Section 51945-4

Warnings

For external use only

Directions

Apply as needed. Apply daily to help improve the look of scars.

Questions?

Call toll-free 877.902.2873

Active Ingredients

Allantoin 0.5%

Inactive Ingredients

BUTYROSPERMUM PARKII (SHEA) BUTTER, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, COPERNICIA CERIFERA (CARNAUBA) WAX, THEOBROMA CACAO (COCOA) SEED BUTTER*, OLEA EUROPAEA (OLIVE) FRUIT OIL, SILICA,

When Using This Product

• do not get into eyes.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center Right away.

Structured Label Content

Uses

temporarily protects minor:  cuts  scrapes

 burns

Section 51945-4 (51945-4)

Purpose

Skin Protectant

Warnings

For external use only

Directions

Apply as needed. Apply daily to help improve the look of scars.

Questions?

Call toll-free 877.902.2873

Active Ingredients

Allantoin 0.5%

Inactive Ingredients (Inactive ingredients)

BUTYROSPERMUM PARKII (SHEA) BUTTER, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, COPERNICIA CERIFERA (CARNAUBA) WAX, THEOBROMA CACAO (COCOA) SEED BUTTER*, OLEA EUROPAEA (OLIVE) FRUIT OIL, SILICA,

When Using This Product (When using this product)

• do not get into eyes.

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

[{"name": "BUTYROSPERMUM PARKII (SHEA) BUTTER", "unii": "K49155WL9Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COPERNICIA CERIFERA (CARNAUBA) WAX", "unii": "R12CBM0EIZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICA", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL", "unii": "3W1JG795YI", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYLGLYCERIN", "unii": "147D247K3P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OLEA EUROPAEA (OLIVE) FRUIT OIL", "unii": "6UYK2W1W1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "THEOBROMA CACAO (COCOA) SEED BUTTER", "unii": "512OYT1CRR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALLANTOIN, (R)-", "unii": "J120C6NTXH", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily protects minor:  cuts  scrapes  burns", "Purpose": "Skin Protectant", "Warnings": "For external use only", "Directions": "Apply as needed. Apply daily to help improve the look of scars.", "Questions?": "Call toll-free 877.902.2873", "Active Ingredients": "Allantoin 0.5%", "Inactive ingredients": "BUTYROSPERMUM PARKII (SHEA) BUTTER, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, COPERNICIA CERIFERA (CARNAUBA) WAX, THEOBROMA CACAO (COCOA) SEED BUTTER*, OLEA EUROPAEA (OLIVE) FRUIT OIL, SILICA,", "When using this product": "• do not get into eyes.", "Keep out of reach of children": "If swallowed, get medical help or contact a Poison Control Center Right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:25.864951 · Updated: 2026-03-14T23:10:51.714911