24909-027 Terrasilmed Burn Care

24909-027 Terrasilmed Burn Care
SPL v3
SPL
SPL Set ID 4068afbd-18a2-4bd2-b766-7d7cbdd9e8ef
Route
TOPICAL
Published
Effective Date 2023-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (0.5 g) Menthol (0.15 g)
Inactive Ingredients
Yellow Wax Coconut Oil Silver Stearate Sorbic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-25

Description

Allantoin 0.5%, Menthol 0.15%

Purpose

Allantoin 0.5% - Skin Protectant Menthol 0.15% - Topical Analgesic


Medication Information

Purpose

Allantoin 0.5% - Skin Protectant

Menthol 0.15% - Topical Analgesic

Description

Allantoin 0.5%, Menthol 0.15%

Uses

Helps protect skin and provide temporary relief of pain and itching due to minor burns, sunburn, and skin irritations.

Section 50565-1

Keep out of reach of children.

Section 53414-9

If pregnant or breast-feeding contact physician prior to use.

Section 60561-8

If swallowed, consult a physician.

Warnings

For external use only.

When using this product, do not get into eyes. Do not apply to open wounds or damaged skin. If symptoms persist for more than 7 days discontinue use and consult physician.

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a physician. ​Store at room temperature. May temporarily (washable) discolor skin, nails, and fabrics in sunlight.

Questions?

401-432-7750 or www.aidance.com

Product Label

Active Ingredients

Allantoin 0.5%, Menthol 0.15%

Inactive Ingredients

beeswax, MCT (coconut oil), silver stearate, sorbic acid


Structured Label Content

Uses

Helps protect skin and provide temporary relief of pain and itching due to minor burns, sunburn, and skin irritations.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 53414-9 (53414-9)

If pregnant or breast-feeding contact physician prior to use.

Section 60561-8 (60561-8)

If swallowed, consult a physician.

Purpose

Allantoin 0.5% - Skin Protectant

Menthol 0.15% - Topical Analgesic

Warnings

For external use only.

When using this product, do not get into eyes. Do not apply to open wounds or damaged skin. If symptoms persist for more than 7 days discontinue use and consult physician.

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a physician. ​Store at room temperature. May temporarily (washable) discolor skin, nails, and fabrics in sunlight.

Questions?

401-432-7750 or www.aidance.com

Product Label (Product label)

Active Ingredients (Active ingredients)

Allantoin 0.5%, Menthol 0.15%

Inactive Ingredients (Inactive ingredients)

beeswax, MCT (coconut oil), silver stearate, sorbic acid


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)