Natural Vaginal Care

Manufacturer
Izun Pharmaceuticals Corporation
Effective date
2015-05-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:06:42

Label at a glance#

ProductNatural Vaginal Care
Active ingredientSambucus nigra flower, Echinacea purpurea, Centella Asiatica
Label structure10 sections

Indications and uses

relieves vaginal pain, itching, burning and discomfort

Dosage and administration

Insert 1 applicatorful (2.5cc) into the vagina at bedtime for 14 consecutive nights. Afterwards apply 3 times a week or as needed. Wash applicator after use.

Storage and handling

do not use if seal over tube opening has been punctured do not purchase if carton is open store at 20-25°C (68 to 77°F) keep out of direct sunlight

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients (in each 2.5 g)Purposes
• Sambucus nigra 2xIrritation reducer
tissue repair formula
• Echinacea purpurea 3xIrritation reducer
• Hydrocotyle asiatica 3xIrritation reducer

Uses

INDICATIONS & USAGE SECTION

  • relieves vaginal pain, itching, burning and discomfort

Warnings

WARNINGS SECTION

For vaginal use only.

When using this product

OTC - WHEN USING SECTION

  • do not use tampons, douches or other vaginal products
  • do not exceed the recommended dosage unless directed by a physician

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or does not improve within 7 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health care professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Insert 1 applicatorful (2.5cc) into the vagina at bedtime for 14 consecutive nights.

Afterwards apply 3 times a week or as needed. Wash applicator after use.

Other Information

STORAGE AND HANDLING SECTION

  • do not use if seal over tube opening has been punctured
  • do not purchase if carton is open
  • store at 20-25°C (68 to 77°F)
  • keep out of direct sunlight

Inactive Ingredients

INACTIVE INGREDIENT SECTION

cetyl alcohol, cetyl palmitate, disodium EDTA, hypromellose, methylparaben, polysorbate 60, propylene glycol, silicon dioxide, stearyl alcohol, white petrolatum, water

Questions?

OTC - QUESTIONS SECTION

Call 1-800-956-2595 Monday thru Friday 8am - 5pm EST

SPL UNCLASSIFIED SECTION

Distributed by: Izun Pharmaceuticals Corp.
New York, NY 10022 USA

PRINCIPAL DISPLAY PANEL - 39.7 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Herbal Formula
Natural BioActives

NDC 49589-115-60

Natural Vaginal Care

Vaginal Cream

Relieves Vaginal Pain, Itching,
Burning & Discomfort

  • Fast Acting Relief
  • Soothing Herbal Formula
  • Package includes
    3 reusable applicators

NET WT
1.4 OZ
(39.7 g)

Homeopathic

izun
Pharmaceuticals

PRINCIPAL DISPLAY PANEL - 39.7 g Tube Carton
PRINCIPAL DISPLAY PANEL - 39.7 g Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49589-115-602020-01-31C16284748780-19d75b9d0-1a3b-f424-e053-dadaa90a57ceNatural Vaginal Care

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49589-115-60Natural Vaginal Care40 g in 1 TUBE, WITH APPLICATORCREAM402
49589-115-60Natural Vaginal Care1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49589-115NATURAL VAGINAL CARE (SAMBUCUS NIGRA FLOWER, ECHINACEA PURPUREA, AND CENTELLA ASIATICA) CREAM [IZUN PHARMACEUTICALS CORPORATION]2Legacy NDC, 2 package rows20150529_a74d5d68-5e31-4126-9987-64dc1fd1521e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Centella AsiaticaACTIVE INGREDIENT7M867G6T1U2
Echinacea purpureaACTIVE INGREDIENTQI7G114Y982
Sambucus nigra flowerACTIVE INGREDIENT07V4DX094T2
Centella AsiaticaACTIVE MOIETY7M867G6T1U2
Echinacea purpureaACTIVE MOIETYQI7G114Y982
Sambucus nigra flowerACTIVE MOIETY07V4DX094T2
cetyl alcoholINACTIVE INGREDIENT936JST6JCN2
cetyl palmitateINACTIVE INGREDIENT5ZA2S6B08X2
edetate disodiumINACTIVE INGREDIENT7FLD91C86K2
hypromellose 2208 (15000 mpa.s)INACTIVE INGREDIENTZ78RG6M2N22
methylparabenINACTIVE INGREDIENTA2I8C7HI9T2
petrolatumINACTIVE INGREDIENT4T6H12BN9U2
polysorbate 60INACTIVE INGREDIENTCAL22UVI4M2
propylene glycolINACTIVE INGREDIENT6DC9Q167V32
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU42
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1Y2
waterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49589-11549589-115-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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 6 · 359 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
polysorbate 60POLYSORBATE 60CAL22UVI4MTABLET, COATED / ORALNAExact identifier — unii candidate
13 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii candidate
49 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / EPIDURAL30 mgExact identifier — unii candidate
79 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED / ORAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS19 mgExact identifier — unii candidate
77 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KTABLET, ORALLY DISINTEGRATING / ORAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii candidate
79 equally ranked IID candidates
stearyl alcoholSTEARYL ALCOHOL2KR89I4H1YSUPPOSITORY / VAGINAL8.5 mgExact identifier — unii candidate
12 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii candidate
81 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNSUSPENSION / AURICULAR (OTIC)1 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KINJECTION / INTRA-ARTICULAR0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSUPPOSITORY / VAGINALNAExact identifier — unii candidate
79 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CLOTH / TOPICAL0.03 mg/mgExact identifier — unii candidate
81 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4SUSPENSION, EXTENDED RELEASE / ORAL70 mgExact identifier — unii candidate
49 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3399 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
81 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING / ORAL68 mgExact identifier — unii candidate
49 equally ranked IID candidates
polysorbate 60POLYSORBATE 60CAL22UVI4MSUPPOSITORY / RECTAL0.05 mg/mgExact identifier — unii candidate
13 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TAEROSOL, FOAM / VAGINAL0.1 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNAEROSOL / TOPICAL1.16 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / SOFT TISSUE1 mgExact identifier — unii candidate
77 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS6 mgExact identifier — unii candidate
77 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TJELLY / TOPICAL420 mgExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / RESPIRATORY (INHALATION)0.03 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
79 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KGEL / OPHTHALMIC396 mgExact identifier — unii candidate
77 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET / BUCCAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KINJECTION / INTRABURSAL0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / ORAL388 mgExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TOINTMENT / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSYRUP / ORAL81 mgExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
hypromellose 2208 (15000 mpa.s)HYPROMELLOSE 2208 (15000 MPA.S)Z78RG6M2N2TABLET / BUCCAL17 mgExact identifier — unii candidate
6 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNTABLET / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TPOWDER / ORALNAExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / PARENTERAL18 mgExact identifier — unii candidate
79 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / RECTAL1214 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / RECTAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / AURICULAR (OTIC)10 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii candidate
79 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4LOZENGE / ORAL120 mgExact identifier — unii candidate
49 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TTABLET, COATED / ORAL0.8 mgExact identifier — unii candidate
79 equally ranked IID candidates
polysorbate 60POLYSORBATE 60CAL22UVI4MSUPPOSITORY / VAGINAL0.03 mgExact identifier — unii candidate
13 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KCREAM / VAGINAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
cetyl palmitateCETYL PALMITATE5ZA2S6B08XSOLUTION / TOPICAL0.05 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE / ORAL300 mgExact identifier — unii candidate
49 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TLIQUID / ORAL162 mgExact identifier — unii candidate
79 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4SYSTEM / TRANSDERMAL35 mgExact identifier — unii candidate
49 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3GEL / OPHTHALMIC0.44 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TAEROSOL, FOAM / TOPICAL6 mgExact identifier — unii candidate
79 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
77 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / TOPICAL1800 mgExact identifier — unii candidate
81 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4SUSPENSION / ORAL400 mgExact identifier — unii candidate
49 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
7a7247e7-5513-4c7b-baf9-680eac576525a74d5d68-5e31-4126-9987-64dc1fd1521e2015-05-27WarningsExact identifier
spl id: 7a7247e7-5513-4c7b-baf9-680eac576525
spl set id: a74d5d68-5e31-4126-9987-64dc1fd1521e

Reported adverse events (FAERS/openFDA)#

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