TERRASILMED INFECTION CONTROL AND PROTECTION- allantoin,benzethonium chloride ointment
Aidance Skincare & Topical Solutions, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients Purpose

Allantoin 0.5% Skin Protectant
Benzethonium Chloride 0.1% First Aid Antiseptic

Uses

Helps protect skin and supports healing of minor cuts, scrapes, burns and wounds, including pressure sores, diabetic ulcers and cracked skin. Topical antiseptic to help decrease the risk of skin infection.

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.

Keep out of reach of children. If swallowed, consult a physician.

Directions

Wash and dry affected skin. Apply a thin layer of product. Cover affected area with a clean bandage. Repeat procedure as directed by healthcare provider or daily until affected area improves. Store at room temperature. May stain fabrics.

Inactive ingredients

Beeswax, MCT (coconut oil), Petrolatum, Silver Stearate, Sorbic Acid

Questions?

401-432-7750 or www.aidance.com

Product label

image description

TERRASILMED INFECTION CONTROL AND PROTECTION
allantoin,benzethonium chloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24909-025
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.5 g in 100 g
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	0.1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
YELLOW WAX (UNII: 2ZA36H0S2V)
COCONUT OIL (UNII: Q9L0O73W7L)
PETROLATUM (UNII: 4T6H12BN9U)
SILVER STEARATE (UNII: 4H6PCL92ZN)
SORBIC ACID (UNII: X045WJ989B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:24909-025-50	50 g in 1 TUBE; Type 0: Not a Combination Product	05/08/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/08/2023

Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)

Name	Address	ID/FEI	Business Operations
Establishment
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-025)