VAGISIL Anti-Itch Medicated Wipes Maximum Strength

Manufacturer
Combe Incorporated | Combe Laboratories, Inc.
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:41:41

Label at a glance#

ProductVAGISIL Anti-Itch Medicated Wipes Maximum Strength
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure21 sections

Dosage and administration

adults and children 12 years and older                             Unfold towelette and gently pat or wipe external vaginal area from front to back. Use each towelette only once and then throw away. Apply to affected area not more than 3 to 4 times daily. Do not flush. children under 12 years consult a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

VAGISIL Anti-Itch Medicated Wipes

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pramoxine hydrochloride 1% (w/w)

Purpose

OTC - PURPOSE SECTION

External analgesic

Use

INDICATIONS & USAGE SECTION

temporarily relieves itching

Warnings

WARNINGS SECTION

For external use only

Avoid contact with eyes

Stop use and ask doctor if

OTC - STOP USE SECTION

condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

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

adults and children
12 years and older          

                 
Unfold towelette and gently pat or wipe external vaginal area from front to back. Use each towelette only once and then throw away. Apply to affected area not more than 3 to 4 times daily. Do not flush.
children under 12 yearsconsult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, polysorbate 20, glycerin, phenoxyethanol, disodium cocoamphodiacetate, TEA-cocoyl glutamate, ethylparaben, disodium EDTA, methylparaben, fragrance, PEG-7 glyceryl cocoate, aloe barbadensis leaf extract, tocopheryl acetate, maltodextrin

SPL UNCLASSIFIED SECTION

VAGISIL Maximum Strength Medicated Anti-Itch Wipes

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pramoxine hydrochloride 1% (w/w)

Purpose

OTC - PURPOSE SECTION

External analgesic

Use

INDICATIONS & USAGE SECTION

Temporarily relieves itching

Warnings

WARNINGS SECTION

For external use only

Avoid contact with eyes

Stop use and ask doctor if

OTC - STOP USE SECTION

condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

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

adults and children
12 years and older          

Unfold towelette and gently pat or wipe external vaginal area from front to back. Use each towelette only once and then throw away. Apply to affected area not more than 3 to 4 times daily. Do not flush.
children under 12 yearsconsult a doctor

Other information

OTHER SAFETY INFORMATION

store at room temperature

discard within 2 months of opening

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, polysorbate 20, glycerin, phenoxyethanol, disodium cocoamphodiacetate, TEA-cocoyl glutamate, ethylparaben, disodium EDTA, methylparaben, fragrance, PEG-7 glyceryl cocoate, aloe barbadensis leaf extract, tocopheryl acetate, maltodextrin

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Maximum Strength
Vagisil
®

Medicated Anti-Itch Wipes

Instant Relief From Intense Itch

Gynecologist Tested

Clinically Tested

  • On-the-go relief
  • With Aloe & Vitamin E
  • Patented Odor Block Technology

12 individually wrapped disposable wipes

5 in. x 7.28 in. (12.7 cm x 18.5 cm)

Maximum Strength Vagisil® Medicated Anti-Itch Wipes Instant Relief From Intense Itch Gynecologist Tested Clinically Tested • On-the-go relief • With Aloe & Vitamin E • Patented ...Maximum Strength Vagisil® Medicated Anti-Itch Wipes Instant Relief From Intense Itch Gynecologist Tested Clinically Tested • On-the-go relief • With Aloe & Vitamin E • Patented ...

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vagisil®
Maximum Strength

Medicated Anti-Itch Wipes

Gynecologist Tested

Instant Relief From Intense Itch

  • With Aloe & Vitamin E
  • Patented Odor Block Technology

20 soft, disposable wipes

5 in. x 7.28 in. (12.7 cm x 18.5 cm)

Principal Display Panel Vagisil® Maximum Strength Medicated Anti-Itch Wipes Gynecologist Tested Instant Relief From Intense Itch • With Aloe & Vitamin E • Patented Odor Block Te...Principal Display Panel Vagisil® Maximum Strength Medicated Anti-Itch Wipes Gynecologist Tested Instant Relief From Intense Itch • With Aloe & Vitamin E • Patented Odor Block Te...

Vagisil® Maximum Strength Medicated Anti-Itch Wipes Gynecologist Tested Instant Relief From Intense Itch • With Aloe & Vitamin E • Patented Odor Block Technology 20 soft, dispos...Vagisil® Maximum Strength Medicated Anti-Itch Wipes Gynecologist Tested Instant Relief From Intense Itch • With Aloe & Vitamin E • Patented Odor Block Technology 20 soft, dispos...

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039541pramoxine HCl 1 % Medicated PadPSN9
1039550Vagisil 1 % Medicated PadPSN9
1039550pramoxine hydrochloride 10 MG/ML Medicated Pad [Vagisil Wipes]SBD9
1039541pramoxine hydrochloride 10 MG/ML Medicated PadSCD9
1039541pramoxine hydrochloride 1 % Medicated PadSY9
1039541pramoxine hydrochloride 1 % Medicated WipeSY9
1039550Vagisil 1 % Medicated WipesSY9
1039550Vagisil Wipes 10 MG/ML Medicated PadSY9

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11509-5035-1VAGISIL Anti-Itch Medicated Wipes Maximum Strength4.5 g in 1 PACKETCLOTH4.59
11509-5035-1VAGISIL Anti-Itch Medicated Wipes Maximum Strength12 in 1 CARTONCLOTH129
11509-5058-1VAGISIL Anti-Itch Medicated Wipes Maximum Strength3.4 g in 1 PACKETCLOTH3.49
11509-5058-1VAGISIL Anti-Itch Medicated Wipes Maximum Strength20 in 1 POUCHCLOTH209

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11509-5035VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]9Current NDC, Legacy NDC, 2 package rows20241211_b848f53d-8aea-4efe-aa2c-009d5121fc33.zip
11509-5058VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]9Current NDC, Legacy NDC, 2 package rows20241211_b848f53d-8aea-4efe-aa2c-009d5121fc33.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11509-5035-1EA - Each11509-5035e1c44b32-37dc-49d1-b8c1-d95fe3bdc5e412022-06-06
11509-5058-1EA - Each11509-5058e1d89e89-07ec-490b-9e73-0797eb5dbc3a12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L56
PRAMOXINEACTIVE MOIETY068X84E0566
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW86
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X6
DISODIUM COCOAMPHODIACETATEINACTIVE INGREDIENT18L9G3U51M6
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K6
ETHYLPARABENINACTIVE INGREDIENT14255EXE396
GLYCERININACTIVE INGREDIENTPDC6A3C0OX6
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T6
PEG-7 GLYCERYL COCOATEINACTIVE INGREDIENTVNX72515436
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T6
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH6
TRIETHANOLAMINE COCOYL GLUTAMATEINACTIVE INGREDIENTLA19WH54UL6
WATERINACTIVE INGREDIENT059QF0KO0R6

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
11509-503511509-5035-1
11509-505811509-5058-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Source Document#

Source XML · Source PDF

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 4 · 220 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DPASTE / ORAL1050 mgExact identifier — unii candidate
60 equally ranked IID candidates
ETHYLPARABENETHYLPARABEN14255EXE39SOLUTION / ORAL14 mgExact identifier — unii candidate
16 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / TOPICAL0.24 %w/vExact identifier — unii+route
56 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route
24 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, EFFERVESCENT / ORAL14404 mgExact identifier — unii candidate
60 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, COATED / ORAL5.6 mgExact identifier — unii candidate
60 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii candidate
60 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TAEROSOL, FOAM / TOPICAL0.16 %w/wExact identifier — unii+route
56 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DPASTE / ORAL1050 mgExact identifier — unii candidate
60 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYSTEM / TOPICAL126 mgExact identifier — unii+route
44 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii+route
24 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / TOPICAL1 mgExact identifier — unii+route
44 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route
56 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSHAMPOO / TOPICAL0.15 %w/wExact identifier — unii+route
56 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii+route
24 equally ranked IID candidates
ETHYLPARABENETHYLPARABEN14255EXE39SUSPENSION / ORAL8 mgExact identifier — unii candidate
16 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii+route
24 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DPOWDER, FOR SUSPENSION / ORAL8000 mgExact identifier — unii candidate
60 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route
24 equally ranked IID candidates
ETHYLPARABENETHYLPARABEN14255EXE39SUSPENSION / ORAL8 mgExact identifier — unii candidate
16 equally ranked IID candidates
ETHYLPARABENETHYLPARABEN14255EXE39GRANULE, FOR SOLUTION / ORAL14 mgExact identifier — unii candidate
16 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DSOLUTION / ORAL1451 mgExact identifier — unii candidate
60 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, EFFERVESCENT / ORAL14404 mgExact identifier — unii candidate
60 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DSUSPENSION / ORAL6040 mgExact identifier — unii candidate
60 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route
24 equally ranked IID candidates
ETHYLPARABENETHYLPARABEN14255EXE39SOLUTION / ORAL14 mgExact identifier — unii candidate
16 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route
44 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, ORALLY DISINTEGRATING / ORAL12 mgExact identifier — unii candidate
60 equally ranked IID candidates
DISODIUM COCOAMPHODIACETATEDISODIUM COCOAMPHODIACETATE18L9G3U51MSHAMPOO, SUSPENSION / TOPICAL5 %w/vExact identifier — unii+route
4 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route
24 equally ranked IID candidates
ETHYLPARABENETHYLPARABEN14255EXE39GRANULE, FOR SOLUTION / ORAL14 mgExact identifier — unii candidate
16 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TEMULSION / TOPICAL0.2 %w/wExact identifier — unii+route
56 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii+route
44 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, CHEWABLE / ORAL292 mgExact identifier — unii candidate
60 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route
44 equally ranked IID candidates
ETHYLPARABENETHYLPARABEN14255EXE39POWDER, FOR SOLUTION / ORAL13 mgExact identifier — unii candidate
16 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii+route
56 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DSUSPENSION / ORAL6040 mgExact identifier — unii candidate
60 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSHAMPOO, SUSPENSION / TOPICAL0.15 %w/wExact identifier — unii+route
56 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TAEROSOL, FOAM / TOPICAL0.16 %w/wExact identifier — unii+route
56 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / TOPICAL0.24 %w/vExact identifier — unii+route
56 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DGRANULE, FOR SUSPENSION / ORAL952 mgExact identifier — unii candidate
60 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, COATED / ORAL5.6 mgExact identifier — unii candidate
60 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route
44 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSHAMPOO, SUSPENSION / TOPICAL0.15 %w/wExact identifier — unii+route
56 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii+route
44 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DLOZENGE / ORAL175 mgExact identifier — unii candidate
60 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DCAPSULE / ORAL200 mgExact identifier — unii candidate
60 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, EFFERVESCENT / ORAL14404 mgExact identifier — unii candidate
60 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / TOPICAL216 mgExact identifier — unii+route
56 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCLOTH / TOPICALNAExact identifier — unii+route+dosage form
4 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii+route
56 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DPASTE / ORAL1050 mgExact identifier — unii candidate
60 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii+route
24 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route
56 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TJELLY / TOPICAL420 mgExact identifier — unii+route
56 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii+route
24 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route
24 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route
44 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
VAGISIL Anti-Itch Medicated Wipes Maximum StrengthPRAMOXINE HYDROCHLORIDECombe Incorporatedb848f53d-8aea-4efe-aa2c-009d5121fc332024-12-12WarningsExact identifier
ndc (package): 11509-5035-1
ndc (package): 11509-5058-1
ndc (product): 11509-5035
ndc (product): 11509-5058
ndc11 (package): 11509505801
ndc11 (package): 11509503501
spl id: d52bff6a-9386-4ff7-a2ff-bef4a6ad07f8
spl set id: b848f53d-8aea-4efe-aa2c-009d5121fc33

Reported adverse events (FAERS/openFDA)#

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