TERRASIL ITCH, RASH AND PAIN RELIEF - allantoin, lidocaine 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 Ingredients

Allantoin 0.5%, Lidocaine HCL 0.5%

Purpose

Allantoin - Skin Protectant

Lidocaine HCL - Topical Anesthetic

Uses

For temporary protection and relief of 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 swallowed, consult physician. Do not bandage tightly.
If pregnant or breast feeding, contact physician prior to use.

Keep out of reach of children.

If swallowed, consult physician.

Directions

Apply directly to effected area. Do not use more than four
times per day. Store at room temperature.

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL - 44g Label

Jar Label

TERRASIL ITCH, RASH AND PAIN RELIEF
allantoin, lidocaine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24909-123
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
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)	Lidocaine Hydrochloride	0.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
BENTONITE (UNII: A3N5ZCN45C)
EUCALYPTUS OIL (UNII: 2R04ONI662)
JOJOBA OIL (UNII: 724GKU717M)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
PEPPERMINT OIL (UNII: AV092KU4JH)
SILVER OXIDE (UNII: 897WUN6G6T)
WHITE WAX (UNII: 7G1J5DA97F)
ZINC OXIDE (UNII: SOI2LOH54Z)

#	Item Code	Package Description
Packaging
1	NDC:24909-123-14	14 g in 1 JAR
2	NDC:24909-123-44	44 g in 1 JAR

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	09/07/2012

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

Name	Address	ID/FEI	Business Operations
Establishment
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-123) , label(24909-123)