Terrasil Rapid-Relief Vaginal - Aidance Skincare & Topical Solutions, LLC

Manufacturer
Aidance Skincare & Topical Solutions, LLC
Effective date
2014-04-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:39:07

Label at a glance#

ProductTerrasil Rapid-Relief Vaginal
Active ingredientMICONAZOLE NITRATE
Label structure7 sections

Indications and uses

Treats vaginal yeast infections.

Dosage and administration

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 area daily. Store at room temperature.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

Purpose

OTC - PURPOSE SECTION

Vaginal Antifungal

Uses

INDICATIONS & USAGE SECTION

Treats vaginal yeast infections.

Warnings

WARNINGS SECTION

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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vaginal Discomfort

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

All Natural

terrasil

RAPID-RELIEF VAGINAL OINTMENT

Plus Medicated Cleansing Bar

2.5X FASTER

compared to leading brands
in scientific studies

THE END OF SUFFERING

Healing and Relief Since 2004

BoxBox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1535503{1 (75000 MG) (miconazole nitrate 0.02 MG/MG Medicated Bar Soap) / 1 (25000 MG) (miconazole nitrate 0.02 MG/MG Vaginal Ointment) } PackGPCK1
1535168miconazole nitrate 2 % Medicated Bar SoapPSN1
1535503miconazole nitrate 2 % Medicated Bar Soap (75 GM) / miconazole nitrate 2 % Vaginal Ointment (25 GM) PackPSN1
1535160miconazole nitrate 2 % Vaginal OintmentPSN1
1535168miconazole nitrate 0.02 MG/MG Medicated Bar SoapSCD1
1535160miconazole nitrate 0.02 MG/MG Vaginal OintmentSCD1
1535168miconazole nitrate 2 % Medicated Bar SoapSY1
1535160miconazole nitrate 2 % Vaginal OintmentSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MICONAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24909-162-252020-01-31C16284748780-19d75b9d0-22db-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24909-162-25Terrasil Rapid-Relief Vaginal1 in 1 PACKAGE, COMBINATIONKIT11
24909-172-25Terrasil Rapid-Relief Vaginal25 g in 1 TUBEOINTMENT25 g2 g in 100g1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24909-162TERRASIL RAPID-RELIEF VAGINAL (MICONAZOLE NITRATE) KIT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]1Legacy NDC, 2 package rows20140429_a28b1c33-d21e-493f-9978-54aba9a9c436.zip
24909-172TERRASIL RAPID-RELIEF VAGINAL (MICONAZOLE NITRATE) KIT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]1Unmatched20140429_a28b1c33-d21e-493f-9978-54aba9a9c436.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1K1
MICONAZOLEACTIVE MOIETY7NNO0D7S5M1
BENTONITEINACTIVE INGREDIENTA3N5ZCN45C1
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7L1
ETIDRONATE TETRASODIUMINACTIVE INGREDIENTCZZ9T1T1X41
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
JOJOBA OILINACTIVE INGREDIENT724GKU717M1
LAURIC ACIDINACTIVE INGREDIENT1160N9NU9U1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H81
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71G1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E1
PALM ACIDINACTIVE INGREDIENTB6G0Y5Z6161
PALM KERNEL ACIDINACTIVE INGREDIENT79P21R43171
PENTASODIUM PENTETATEINACTIVE INGREDIENT961TOZ5L7T1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JH1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SAGE OILINACTIVE INGREDIENTU27K0H1H2O1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y1
SILVER OXIDEINACTIVE INGREDIENT897WUN6G6T1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP01
SODIUM PALM KERNELATEINACTIVE INGREDIENT6H91L1NXTW1
SODIUM PALMATEINACTIVE INGREDIENTS0A6004K3Z1
SODIUM STEARATEINACTIVE INGREDIENTQU7E2XA9TG1
SORBITOLINACTIVE INGREDIENT506T60A25R1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
TEA TREE OILINACTIVE INGREDIENTVIF565UC2G1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
WATERINACTIVE INGREDIENT059QF0KO0R1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97F1
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54Z1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24909-16224909-162-25
24909-17224909-172-25
24909-182

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 9 · 486 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii candidate
81 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHPASTE, DENTIFRICE / DENTAL49.3 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / RESPIRATORY (INHALATION)10 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM STEARATESODIUM STEARATEQU7E2XA9TGTABLET, DELAYED RELEASE / ORAL10 mgExact identifier — unii candidate
3 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / VAGINAL1088 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APEMULSION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER, DENTIFRICE / DENTAL0.03 mg/mgExact identifier — unii candidate
134 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TRANSDERMAL500 mgExact identifier — unii candidate
81 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LTABLET / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRABURSAL9 mgExact identifier — unii candidate
134 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS1.04 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SWAB / TOPICAL34.6 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSPRAY / NASAL49 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAOCULAR320 mgExact identifier — unii candidate
134 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE / DENTAL0.5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSYRUP / ORAL40 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRASYNOVIAL0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / PERINEURAL648 mgExact identifier — unii candidate
134 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL / TOPICAL19.2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii candidate
81 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE, DENTIFRICE / DENTAL14 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / DENTALNAExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAMUSCULAR90 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XIMPLANT / SUBCUTANEOUS77 mgExact identifier — unii candidate
134 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii candidate
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / TOPICAL0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FTABLET, COATED / ORAL3 mgExact identifier — unii candidate
15 equally ranked IID candidates
BENTONITEBENTONITEA3N5ZCN45CCAPSULE / ORALADJ PHExact identifier — unii candidate
11 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / RECTAL1214 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii candidate
81 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / OPHTHALMIC6 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APOINTMENT / TOPICAL15 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GTABLET, FILM COATED / ORAL80 mgExact identifier — unii candidate
9 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii candidate
81 equally ranked IID candidates
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GCAPSULE, EXTENDED RELEASE / ORAL75 mgExact identifier — unii candidate
9 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSOLUTION / ORAL53 mgExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRACAUDAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR24 mgExact identifier — unii candidate
134 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRALESIONAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii candidate
26 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / RESPIRATORY (INHALATION)25 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUSNAExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAVESICAL351 mgExact identifier — unii candidate
134 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii candidate
40 equally ranked IID candidates
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GCAPSULE / ORAL20 mgExact identifier — unii candidate
9 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPINSERT, EXTENDED RELEASE / OPHTHALMIC0.4 mgExact identifier — unii candidate
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, COATED / ORAL16 mgExact identifier — unii candidate
81 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3e80a11e-1c5e-43d3-a1b6-94c163bf30d9a28b1c33-d21e-493f-9978-54aba9a9c4362014-04-18WarningsExact identifier
spl id: 3e80a11e-1c5e-43d3-a1b6-94c163bf30d9
spl set id: a28b1c33-d21e-493f-9978-54aba9a9c436

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.