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

Purpose

Skin Protectant

Description

Allantoin 0.5%

Medication Information

Warnings

For external use only

Uses

temporarily protects minor:  cuts  scrapes

 burns

Purpose

Skin Protectant

Directions

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

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,

Description

Allantoin 0.5%

Questions?

Call toll-free 877.902.2873

Section 51945-4

Active Ingredients

Allantoin 0.5%

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

Warnings

For external use only

Uses

temporarily protects minor:  cuts  scrapes

 burns

Purpose

Skin Protectant

Directions

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

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,

Questions?

Call toll-free 877.902.2873

Section 51945-4 (51945-4)

Active Ingredients

Allantoin 0.5%

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