Theraseal Hand Protection

SPL v4

SPL

SPL Set ID 2c8dc616-20c1-4d33-8a89-9bcdb22b35c8

Route

TOPICAL

Published

Effective Date 2015-02-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dimethicone (1.7 g)

Inactive Ingredients

Water Cyclomethicone Polyglyceryl-4 Isostearate Hexyl Laurate Sodium Chloride Imidurea

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2012-01-01

Description

Drug Facts

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

Drug Facts

Uses

Helps prevent and temporarily protect chafed, chapped, cracked, dry skin.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product avoid contact with eyes.

Not to be applied over deep or puncture wounds, infections or lacerations. If condition worsens or does not improve within 7 days, consult a physician.

Section 50570-1

For external use only.

Directions

Apply liberally as often as necessary.

Questions?

1-866-819-9007

www.CoriaLabs.com

Active Ingredient

Dimethicone 1% w/w

Inactive Ingredients

Purified water, cyclomethicone, cyclomethicone aluminum magnesium hydroxide stearate, cetyl dimethicone copolyol and polyglyceryl-4-isostearate and hexyl laurate, sodium chloride, imidurea.

Principal Display Panel 6 Ounce Label

PROTECTS DAMAGED HANDS

TheraSeal _®

Hand Protection

Protects hands from

harmful irritants

SKIN PROTECTANT

NET WT. 6 OZ.

Patented formulation

Structured Label Content

Uses

Helps prevent and temporarily protect chafed, chapped, cracked, dry skin.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes.

Not to be applied over deep or puncture wounds, infections or lacerations. If condition worsens or does not improve within 7 days, consult a physician.

Section 50570-1 (50570-1)

For external use only.

Purpose

Skin Protectant

Directions

Apply liberally as often as necessary.

Questions?

1-866-819-9007

www.CoriaLabs.com

Active Ingredient

Dimethicone 1% w/w

Inactive Ingredients

Purified water, cyclomethicone, cyclomethicone aluminum magnesium hydroxide stearate, cetyl dimethicone copolyol and polyglyceryl-4-isostearate and hexyl laurate, sodium chloride, imidurea.

Principal Display Panel 6 Ounce Label (PRINCIPAL DISPLAY PANEL - 6 ounce label)

PROTECTS DAMAGED HANDS

TheraSeal _®

Hand Protection

Protects hands from

harmful irritants

SKIN PROTECTANT

NET WT. 6 OZ.

Patented formulation

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CYCLOMETHICONE", "unii": "NMQ347994Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYGLYCERYL-4 ISOSTEARATE", "unii": "820DPX33S7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HEXYL LAURATE", "unii": "4CG9F9W01Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "IMIDUREA", "unii": "M629807ATL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "1.7", "strengthDenominator": "170.1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Helps prevent and temporarily protect chafed, chapped, cracked, dry skin.", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "50567-7": "When using this product avoid contact with eyes. Not to be applied over deep or puncture wounds, infections or lacerations. If condition worsens or does not improve within 7 days, consult a physician.", "50570-1": "For external use only.", "Purpose": "Skin Protectant", "Directions": "Apply liberally as often as necessary.", "Questions?": "1-866-819-9007 www.CoriaLabs.com", "Active Ingredient": "Dimethicone 1% w/w", "Inactive Ingredients": "Purified water, cyclomethicone, cyclomethicone aluminum magnesium hydroxide stearate, cetyl dimethicone copolyol and polyglyceryl-4-isostearate and hexyl laurate, sodium chloride, imidurea.", "PRINCIPAL DISPLAY PANEL - 6 ounce label": "PROTECTS DAMAGED HANDS TheraSeal ® Hand Protection Protects hands from harmful irritants SKIN PROTECTANT NET WT. 6 OZ. Patented formulation"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:52.559753 · Updated: 2026-03-14T23:04:10.666734