TERRASIL ITCH, RASH AND PAIN RELIEF- allantoin, menthol ointment

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredients

Allantoin 0.5%, Menthol 0.1%

Purpose

Allantoin - Skin Protectant
Menthol - Topical Anesthetic

Uses

For temporary relief and protection from pain and itching associated with minor skin irritations, rashes, eczema and/or insect bites.

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 breast feeding, contact physician prior to use.

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

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 stain fabrics.

Inactive Ingredients

beeswax (organic), bentonite (volcanic clay)**,  cotton seed oil, eucalyptus citriodora oil, jojoba seed oil, magnesium oxide, peppermint oil, silver oxide, vegetable stearic acid (naturally sourced), zinc oxide.

**may contain this ingredient.

PRINCIPAL DISPLAY PANEL 

All Natural
terrasil®
ITCH, RASH & PAIN RELIEF OINTMENT
with Activated Minerals®

INGREDIENTS AND APPEARANCE

TERRASIL ITCH, RASH AND PAIN RELIEF 
allantoin, menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-159
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
BENTONITE (UNII: A3N5ZCN45C)
COTTONSEED OIL (UNII: H3E878020N)
EUCALYPTUS OIL (UNII: 2R04ONI662)
JOJOBA OIL (UNII: 724GKU717M)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
PEPPERMINT OIL (UNII: AV092KU4JH)
SILVER OXIDE (UNII: 897WUN6G6T)
STEARIC ACID (UNII: 4ELV7Z65AP)
WHITE WAX (UNII: 7G1J5DA97F)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-159-50	50 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2017
2	NDC: 24909-159-14	14 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/01/2017

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

Establishment
Name	Address	ID/FEI	Business Operations
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-159) , label(24909-159)