TERRASIL BURN CARE AND RELIEF- allantoin, menthol ointment

Terrasil Burn Care and Relief by

Drug Labeling and Warnings

Terrasil Burn Care and Relief by is a Otc medication manufactured, distributed, or labeled by Aidance Skincare & Topical Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Allantoin 0.5%.........................Skin Protectant

Menthol 0.1% .........................Topical Analgesic

PURPOSE

Uses

For temporary relief of pain and itching due to minor burns, sunburn and skin irritations.

Warnings

For external use only.

Avoid contact with eyes. Do not apply to open wounds or damaged skin.

If symptoms persist for more than seven days, discontinue use and consult physician.

If pregnant or breastfeeding, contact physician prior to use.

Keep out of reach of children. If swallowed, consult Poison Control.

KEEP OUT OF REACH OF CHILDREN

Directions

Apply directly to affected area. Do not use more than 4 times per day. Do not bandage damaged skin. Store at room temperature. May
temporarily (washable) discolor skin and fabrics in sunlight.

Inactive ingredients

beeswax, cottonseed oil, eucalyptus oil, jojoba oil, magnesium oxide, peppermint oil, silver stearate, zinc oxide.

Product label

INGREDIENTS AND APPEARANCE

TERRASIL BURN CARE AND RELIEF 
allantoin, menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-194
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
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WHITE WAX (UNII: 7G1J5DA97F)
COTTONSEED OIL (UNII: H3E878020N)
EUCALYPTUS OIL (UNII: 2R04ONI662)
JOJOBA OIL (UNII: 724GKU717M)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
PEPPERMINT OIL (UNII: AV092KU4JH)
SILVER STEARATE (UNII: 4H6PCL92ZN)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-194-50	50 g in 1 TUBE; Type 0: Not a Combination Product	01/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	01/15/2020

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

Establishment
Name	Address	ID/FEI	Business Operations
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-194)