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Terrasil Itch, Rash and Pain Relief

Dosage form: ointment
Ingredients: Allantoin 0.5g in 100g, Lidocaine Hydrochloride 0.5g in 100g
Labeler: Aidance Skincare & Topical Solutions, LLC
NDC Code: 24909-123

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.

Drug Facts

Active Ingredients

Allantoin 0.5%, Lidocaine HCL 0.5%

Purpose

Allantoin - Skin Protectant

Lidocaine HCL - Topical Anesthetic

UsesFor 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

TERRASIL ITCH, RASH AND PAIN RELIEF 
allantoin, lidocaine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-123
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (Allantoin) Allantoin0.5 g  in 100 g
Lidocaine Hydrochloride (Lidocaine ) Lidocaine Hydrochloride0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENTONITE 
EUCALYPTUS OIL 
JOJOBA OIL 
MAGNESIUM OXIDE 
PEPPERMINT OIL 
SILVER OXIDE 
WHITE WAX 
ZINC OXIDE 
Packaging
#Item CodePackage Description
1NDC:24909-123-1414 g in 1 JAR
2NDC:24909-123-4444 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/07/2012
Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
Establishment
NameAddressID/FEIOperations
Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-123), label(24909-123)

Revised: 09/2012
 
Aidance Skincare & Topical Solutions, LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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