TERRASIL SKIN REPAIR MAX- allantoin, benzethonium chloride ointment

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredients

Allantoin 1%

Benzethonium Chloride 0.2%

Purpose

Allantoin - Skin Protectant

Benzethonium Chloride - Antiseptic

Uses

• Helps protect skin and supports healing of skin lesions, ulcers, sores, blisters, cracked or damaged skin and lips.
• Helps relieve minor skin irritation and itching due to rashes.
  
• 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, 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

bentonite, cedarwood himalayan oil, cera alba (organic beeswax), magnesium oxide, peppermint oil, silver oxide, simmondsia chinensis (jojoba) seed oil, tea tree oil, zinc oxide

PRINCIPAL DISPLAY PANEL - 44g Label

INGREDIENTS AND APPEARANCE

TERRASIL SKIN REPAIR  MAX
allantoin, benzethonium chloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-132
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	1 g  in 100 g
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	0.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BENTONITE (UNII: A3N5ZCN45C)
CEDRUS DEODARA WOOD OIL (UNII: 01O086PVD0)
JOJOBA OIL (UNII: 724GKU717M)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
PEPPERMINT OIL (UNII: AV092KU4JH)
SILVER OXIDE (UNII: 897WUN6G6T)
TEA TREE OIL (UNII: VIF565UC2G)
WHITE WAX (UNII: 7G1J5DA97F)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-132-14	14 g in 1 JAR
2	NDC: 24909-132-44	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	09/07/2012

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

Establishment
Name	Address	ID/FEI	Business Operations
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-132) , label(24909-132)