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

Drug Labeling and Warnings

Drug Details [pdf]

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 pregnant or breast feeding, contact physician prior to use.

Keep out of reach of children.

If swallowed, consult physician.

Directions

Ointment: Apply directly to affected area. Do not use more than four
times per day. Store at room temperature. May stain fabrics.

Cleansing Bar: Wash affected area daily.

Inactive Ingredients

Ointment: beeswax (organic), bentonite (volcanic clay), eucalyptus citriodora oil, jojoba seed oil, magnesium oxide, peppermint oil, silver oxide, zinc oxide.

Cleansing Bar: beeswax, bentonite clay, coconut oil, eucalyptus oil, glycerin, jojoba seed oil, lauric acid, lavender oil, magnesium oxide, olive oil, palm acid, palm kernel acid, pentasodium pentetate, peppermint oil, propylene glycol, purified water, silver oxide, sodium stearate, sorbitol, shea butter, sodium laureth sulphate (SLES), stearic acid, sodium chloride, sodium palmate, sodium palm kernelate, sorbitol, titanium dioxide, tetrasodium etidronate, zinc oxide.

PRINCIPAL DISPLAY PANEL - BOX

Itch, Rash & Pain

• Penetrating Pain and Intense Itching
• Eczema, Dermatitis, Insect Bites
• Rashes and Red Irritated Skin

All Natural

terrasil

ITCH, RASH & PAIN RELIEF OINTMENT

Plus Medicated Cleansing Bar

FAST & EFFECTIVE

itch and pain relief

THE END OF SUFFERING SKIN

Healing and Relief Since 2004

INGREDIENTS AND APPEARANCE

TERRASIL ITCH, RASH AND PAIN RELIEF 
allantoin, lidocaine kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-163

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-163-25	1 in 1 PACKAGE, COMBINATION

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	25 g
Part 2	1 CARTON	75 g

Part 1 of 2

TERRASIL ITCH, RASH AND PAIN RELIEF 
allantoin, lidocaine ointment

Product Information
Item Code (Source)	NDC: 24909-173
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
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-173-25	25 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/18/2014

Part 2 of 2

TERRASIL ITCH, RASH AND PAIN RELIEF MEDICATED CLEANSING BAR 
lidocaine soap

Product Information
Item Code (Source)	NDC: 24909-183
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BENTONITE (UNII: A3N5ZCN45C)
COCONUT OIL (UNII: Q9L0O73W7L)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
JOJOBA OIL (UNII: 724GKU717M)
LAURIC ACID (UNII: 1160N9NU9U)
LAVENDER OIL (UNII: ZBP1YXW0H8)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
OLIVE OIL (UNII: 6UYK2W1W1E)
PALM ACID (UNII: B6G0Y5Z616)
PALM KERNEL ACID (UNII: 79P21R4317)
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)
PEPPERMINT OIL (UNII: AV092KU4JH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILVER OXIDE (UNII: 897WUN6G6T)
SODIUM STEARATE (UNII: QU7E2XA9TG)
SHEA BUTTER (UNII: K49155WL9Y)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PALMATE (UNII: S0A6004K3Z)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)
WATER (UNII: 059QF0KO0R)
WHITE WAX (UNII: 7G1J5DA97F)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		75 g in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/18/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	04/18/2014

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

Establishment
Name	Address	ID/FEI	Business Operations
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-163) , label(24909-163)