TERRASIL ITCH, RASH AND PAIN RELIEF- allantoin, lidocaine 
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 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

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

Box

TERRASIL ITCH, RASH AND PAIN RELIEF 
allantoin, lidocaine kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-163
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-163-251 in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 25 g
Part 21 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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-173-2525 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/18/2014
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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
175 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/18/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34704/18/2014
Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
Establishment
NameAddressID/FEIBusiness Operations
Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-163) , label(24909-163)

Revised: 4/2014
Document Id: 22ac774a-b61a-4d9b-85f6-3c1e835cdb51
Set id: cef12200-923c-49b2-ab11-ec7d9d0e10d8
Version: 1
Effective Time: 20140418
 
Aidance Skincare & Topical Solutions, LLC