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

Jar Label

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

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	0.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

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

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