Label: TERRASIL ITCH, RASH AND PAIN RELIEF- allantoin, lidocaine kit
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Contains inactivated NDC Code(s)
NDC Code(s): 24909-163-25, 24909-173-25 - Packager: Aidance Skincare & Topical Solutions, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated April 18, 2014
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- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
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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.
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INGREDIENTS AND APPEARANCE
TERRASIL ITCH, RASH AND PAIN RELIEF
allantoin, lidocaine kitProduct 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 ointmentProduct 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 soapProduct 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)
