Label: TERRASIL RAPID-RELIEF VAGINAL- miconazole nitrate kit
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Contains inactivated NDC Code(s)
NDC Code(s): 24909-162-25, 24909-172-25 - Packager: Aidance Skincare & Topical Solutions, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
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Warnings
For vaginal use only
Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.
Ask a doctor before use if you have
● vaginal itching and discomfort for the first time
● lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling
vaginal discharge. You may have a more serious condition.
● vaginal yeast infections often (such as once a month or 3 in 6 months).
You could be pregnant or have a serious underlying medical cause for your
symptoms, including diabetes or a weakened immune system.
● been exposed to human immunedeficiency virus (HIV) that causes AIDS.Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine
warfarin, because bleeding or bruising may occur.When using this product
● do not use tampons, douches, spermicides, or other vaginal products.
Condoms and diaphragms may be damaged and fail to prevent pregnancy
or sexually transmitted disease (STDs).
● do not have vaginal intercourse
● mild increase in vaginal burning, itching, or irritation may occur
● if you do not get complete relief ask a doctor before using another productStop use and ask a doctor if
● symptoms do not get better after 3 days
● symptoms last more than 7 days
● you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge.
If pregnant or breast feeding, ask a health professional before use. -
Directions
Children under 12: Ask a doctor.
Adults and children 12 years and over:
Ointment: May be used topically (outside the vaginal area) or intravaginally.
Squeeze a small amount of ointment onto fingertip.
Apply 2-3 times daily for up to 3 days or longer, as needed. May stain fabrics.
Cleansing Bar: Wash affected areadaily. Store at room temperature. -
Inactive Ingredients
Ointment: beeswax (organic), bentonite (volcanic clay), jojoba seed oil, magnesium oxide, peppermint oil, sage oil, silver oxide, tea tree oil, zinc oxide.
Cleansing Bar: beeswax, bentonite clay, 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, tea tree oil, titanium dioxide, tetrasodium etidronate, zinc oxide.
- PRINCIPAL DISPLAY PANEL - BOX
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INGREDIENTS AND APPEARANCE
TERRASIL RAPID-RELIEF VAGINAL
miconazole nitrate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24909-162 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24909-162-25 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 RAPID-RELIEF VAGINAL
miconazole nitrate ointmentProduct Information Item Code (Source) NDC:24909-172 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 g in 100 g Inactive Ingredients Ingredient Name Strength BENTONITE (UNII: A3N5ZCN45C) JOJOBA OIL (UNII: 724GKU717M) MAGNESIUM OXIDE (UNII: 3A3U0GI71G) PEPPERMINT OIL (UNII: AV092KU4JH) SAGE OIL (UNII: U27K0H1H2O) SILVER OXIDE (UNII: 897WUN6G6T) TEA TREE OIL (UNII: VIF565UC2G) WHITE WAX (UNII: 7G1J5DA97F) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24909-172-25 25 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 04/18/2014 Part 2 of 2 TERRASIL MEDICATED VAGINAL CLEANSING BAR
miconazole nitrate soapProduct Information Item Code (Source) NDC:24909-182 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 g in 100 g Inactive Ingredients Ingredient Name Strength BENTONITE (UNII: A3N5ZCN45C) 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) TEA TREE OIL (UNII: VIF565UC2G) 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 final part333C 04/18/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 04/18/2014 Labeler - Aidance Skincare & Topical Solutions, LLC (018950611) Establishment Name Address ID/FEI Business Operations Aidance Skincare & Topical Solutions, LLC 018950611 manufacture(24909-162) , label(24909-162)
