TERRASIL RAPID-CLEAR PSORIASIS- salicylic acid, thuja, sulfur 
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 Ingredient

Ointment: Salicylic Acid 3%
Cleansing Bar: Thuja 3X HPUS, Sulfur 10X HPUS

The letters HPUS indicate the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopeia of the United States

Purpose

Salicylic Acid - Psoriasis and Seborrheic Dermatitis Treatment
Thuja, Sulfur - Psoriasis Relief

Uses

Relieves and helps prevent recurrence of skin: irritation; itching;
redness, flaking; scaling; due to psoriasis and seborrheic dermatitis.

Warnings

For external use only

Ask a doctor before use if you have psoriasis that covers a large area of the body.

When using this product
avoid contact with the eyes. If contact occurs, rinse the eyes
thoroughly with water.

Stop use and ask a doctor if
condition worsens or does not improve after regular use as directed.

Keep out of reach of children.

If swallowed, consult a physician.

Directions

Ointment: Spread thinly on affected areas 1-4 times daily or as directed by a doctor.
Store at room temperature. May stain fabrics.
Cleansing Bar: Wash affected area daily.

Inactive Ingredients

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

Cleansing Bar: beeswax, bentonite clay, cedarwood oil, coconut 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

Psoriasis Therapy

All Natural

terrasil

RAPID-CLEAR PSORIASIS OINTMENT

Plus Medicated Cleansing Bar

FIGHTS PSORIASIS SYMPTOMS

THE END OF SUFFERING SKIN

Healing and Relief Since 2004

Box

TERRASIL RAPID-CLEAR PSORIASIS 
salicylic acid, thuja, sulfur kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-164
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-164-251 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 RAPID-CLEAR PSORIASIS 
salicylic acid ointment
Product Information
Item Code (Source)NDC:24909-174
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENTONITE (UNII: A3N5ZCN45C)  
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:24909-174-2525 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H04/18/2014
Part 2 of 2
TERRASIL PSORIASIS MEDICATED CLEANSING BAR 
thuja, sulfur soap
Product Information
Item Code (Source)NDC:24909-184
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG3 [hp_X]  in 1 g
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENTONITE (UNII: A3N5ZCN45C)  
CEDAR LEAF OIL (UNII: BJ169U4NLG)  
COCONUT OIL (UNII: Q9L0O73W7L)  
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
1NDC:24909-184-7575 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/18/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H04/18/2014
Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
Establishment
NameAddressID/FEIBusiness Operations
Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-164) , label(24909-164)

Revised: 4/2014
Document Id: 4a83f102-02d8-49d2-9abb-734866e13d72
Set id: 423d3f93-3d2f-41c6-81da-e34f29d05624
Version: 1
Effective Time: 20140418
 
Aidance Skincare & Topical Solutions, LLC