TERRASIL RAPID-RELIEF VAGINAL- miconazole nitrate, thuja occidentalis kit

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredient

Ointment: Miconazole Nitrate 2%
Cleansing Bar: Thuja Occidentalis 6X HPUS

Purpose

Vaginal Antifungal

Uses

Treats vaginal yeast infections.

KEEP OUT OF REACH OF CHILDREN

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 product Stop 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), cottonseed oil, jojoba seed oil, magnesium oxide, peppermint oil, sage oil, silver oxide, stearic acid, tea tree oil, zinc oxide.

Cleansing Bar: beeswax, bentonite clay, coconut oil, cottonseed 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, stearic acid, tea tree oil, titanium dioxide, tetrasodium etidronate, zinc oxide.

PRINCIPAL DISPLAY PANEL - BOX

Vaginal Discomfort

• Vaginal Itch
• Odor and Discharge
• Yeast Infection and Vaginitis

All Natural

terrasil

RAPID-RELIEF VAGINAL OINTMENT

Plus Medicated Cleansing Bar

2X FASTER

compared to leading brands
in scientific studies

THE END OF SUFFERING

Healing and Relief Since 2004

INGREDIENTS AND APPEARANCE

TERRASIL RAPID-RELIEF VAGINAL 
miconazole nitrate, thuja occidentalis kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-190

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-190-25	1 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package	01/01/2017

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 ointment

Product Information
Item Code (Source)	NDC: 24909-189
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)
COTTONSEED OIL (UNII: H3E878020N)
JOJOBA OIL (UNII: 724GKU717M)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
PEPPERMINT OIL (UNII: AV092KU4JH)
SAGE OIL (UNII: U27K0H1H2O)
SILVER OXIDE (UNII: 897WUN6G6T)
STEARIC ACID (UNII: 4ELV7Z65AP)
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: 24909-189-25	25 g in 1 TUBE; Type 1: Convenience Kit of Co-Package

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 VAGINAL CLEANSING BAR 
thuja occidentalis soap

Product Information
Item Code (Source)	NDC: 24909-188
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
THUJA OCCIDENTALIS WHOLE (UNII: 5HBV6WCE3N) (MICONAZOLE - UNII:7NNO0D7S5M)	THUJA OCCIDENTALIS WHOLE	6 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENTONITE (UNII: A3N5ZCN45C)
COTTONSEED OIL (UNII: H3E878020N)
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; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/01/2017

Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)

Establishment
Name	Address	ID/FEI	Business Operations
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-190) , label(24909-190)