24909-043 terrasil scar recovery

SPL v1

SPL

SPL Set ID 2a2f91ff-a447-9d2a-e063-6394a90a84f8

Route

topical

Published

Effective Date 2024-12-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

allantoin (0.5 g)

Inactive Ingredients

silver stearate coconut oil zinc oxide tea tree oil sage oil palm oil peppermint oil jojoba oil magnesium oxide stearic acid

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2024-12-27

Purpose

Skin Protectant

Description

Allantoin 0.5%

Medication Information

Warnings

For external use only.

When using this product, do not get into eyes.

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

Do not use on deep or puncture wounds, animal bites or serious burns.

Uses

Helps prevent, temporarily protect, and relieve chapped or cracked skin.

Purpose

Skin Protectant

Directions

Apply as needed. Store at room temperature. May temporarily (washable) discolor skin and fabrics in sunlight.

Inactive Ingredients

beeswax, coconut oil (organic), jojoba oil, magnesium oxide, MCT oil, peppermint oil, sage oil, silver stearate, tea tree oil, vegetable stearic acid (naturally sourced), zinc oxide

Description

Allantoin 0.5%

Questions?

401-432-7750 or www.aidance.com

Section 50565-1

Keep out of reach of children.

Section 60561-8

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

Product Label

Active Ingredient

Allantoin 0.5%

Structured Label Content

Warnings

For external use only.

When using this product, do not get into eyes.

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

Do not use on deep or puncture wounds, animal bites or serious burns.

Uses

Helps prevent, temporarily protect, and relieve chapped or cracked skin.

Purpose

Skin Protectant

Directions

Apply as needed. Store at room temperature. May temporarily (washable) discolor skin and fabrics in sunlight.

Inactive Ingredients (Inactive ingredients)

beeswax, coconut oil (organic), jojoba oil, magnesium oxide, MCT oil, peppermint oil, sage oil, silver stearate, tea tree oil, vegetable stearic acid (naturally sourced), zinc oxide

Questions?

401-432-7750 or www.aidance.com

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 60561-8 (60561-8)

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

Product Label

Active Ingredient

Allantoin 0.5%

Advanced Ingredient Data

[{"name": "SILVER STEARATE", "unii": "4H6PCL92ZN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCONUT OIL", "unii": "Q9L0O73W7L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TEA TREE OIL", "unii": "VIF565UC2G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SAGE OIL", "unii": "U27K0H1H2O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALLANTOIN", "unii": "344S277G0Z", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "PALM OIL", "unii": "5QUO05548Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT OIL", "unii": "AV092KU4JH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "JOJOBA OIL", "unii": "724GKU717M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM OXIDE", "unii": "3A3U0GI71G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Helps prevent, temporarily protect, and relieve chapped or cracked skin.", "50565-1": "Keep out of reach of children.", "60561-8": "If swallowed, get medical help or contact a Poison Control Center right away.", "Purpose": "Skin Protectant", "Warnings": "For external use only. When using this product, do not get into eyes. Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days. Do not use on deep or puncture wounds, animal bites or serious burns.", "Directions": "Apply as needed. Store at room temperature. May temporarily (washable) discolor skin and fabrics in sunlight.", "Questions?": "401-432-7750 or www.aidance.com", "Active Ingredient": "Allantoin 0.5%", "Inactive ingredients": "beeswax, coconut oil (organic), jojoba oil, magnesium oxide, MCT oil, peppermint oil, sage oil, silver stearate, tea tree oil, vegetable stearic acid (naturally sourced), zinc oxide"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:04.350356 · Updated: 2026-03-14T23:06:23.767952