TERRASIL WOUND CARE- allantoin 0.5%, benzethonium chloride 0.5% ointment

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredient

Allantoin 0.5%

Benzethonium Chloride 0.5%

Purpose

Allantoin - Skin Protectant

Benzethonium Chloride - Antiseptic

Uses

Temporarily protects minor cuts, scrapes, burns. Helps relieve chapped or cracked skin and lips. Helps protect from the drying effects of wind and cold weather. First aid 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, call poison control or seek medical help.

Directions

Wash and dry affected skin. Apply a thin layer of Terrasil. Cover affected area with a clean bandage. Repeat procedure 2-3 times daily until skin improves. Store at room temperature.

Inactive Ingredients

(Organic) Beeswax, Bentonite, Simmondsia Chinensis (Jojoba) Seed Oil, Magnesium Oxide, Peppermint Oil, Sage Oil, Silver Oxide,
Zinc Oxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TERRASIL WOUND CARE  
allantoin 0.5%, benzethonium chloride 0.5% ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-115
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z)	Allantoin	0.5 g  in 100 g
Benzethonium Chloride (UNII: PH41D05744) (Benzethonium - UNII:1VU15B70BP)	Benzethonium Chloride	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WHITE WAX (UNII: 7G1J5DA97F)
BENTONITE (UNII: A3N5ZCN45C)
JOJOBA OIL (UNII: 724GKU717M)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
PEPPERMINT OIL (UNII: AV092KU4JH)
SAGE OIL (UNII: U27K0H1H2O)
SILVER OXIDE (UNII: 897WUN6G6T)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-115-44	44 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	01/20/2012

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

Establishment
Name	Address	ID/FEI	Business Operations
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture, label