FDA.reportPublic FDA data

LOLA Vaginal Itch Relief Wipes

Manufacturer
Alyk, Inc.
Effective date
2021-04-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:40:41

Label at a glance#

ProductLOLA Vaginal Itch Relief Wipes
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure11 sections

Dosage and administration

Adults and children 12 years and older. Unfold towelette and gently wipe external vaginal area. Use each towelette only once and then throw away. Use no more than 3 to 4 times daily.

Storage and handling

Use according to package label instructions. Keep in cool storage.

Label contents#

Full prescribing information#

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

OTC - STOP USE SECTION

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

Do Not Use

OTC - DO NOT USE SECTION

  • Skin: This product is expected to contact with skin. If irritation is experienced, discontinue use of product. If discomfort persists, seek medical attention.
  • Eye: Hold eyelid open and flush with water for at least 15 minutes. If irritation persists, seek medical attention.
  • Ingestion: Wipes may present a choking hazard. Accidental ingestion may necessitate medical attention.
  • Inhalation: Not likely to be inhaled. If symptomatic, remove to fresh air.

Keep out of reach of children

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

Adults and children 12 years and older. Unfold towelette and gently wipe external vaginal area. Use each towelette only once and then throw away. Use no more than 3 to 4 times daily.

Other Information

STORAGE AND HANDLING SECTION

Use according to package label instructions. Keep in cool storage.

Inactive Ingredient(s)

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Avena Sativa (Oat) Bran Extract, Bisabolol, Citric Acid, Decyl Glucoside, Gluconic Acid, Glycerin, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Polyglyceryl-4 Caprate, Polyglyceryl-6 Caprylate, Saccharomyces Ferment Filtrate, Sodium Benzoate, Tetrasodium Glutamate Diacetate, Tocopherol, Vinegar (Apple Cider), Water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

28ct in 1 pouch NDC 81032-422-2828ct in 1 pouch NDC 81032-422-28

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039541pramoxine HCl 1 % Medicated PadPSN2
1039541pramoxine hydrochloride 10 MG/ML Medicated PadSCD2
1039541pramoxine hydrochloride 1 % Medicated PadSY2
1039541pramoxine hydrochloride 1 % Medicated WipeSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81032-422-282024-01-30C16284748780-11030e365-4f63-111a-e063-dadaa90a10e2be77387d-5f48-4592-e053-2a95a90a384d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81032-422-28LOLA Vaginal Itch Relief Wipes28 in 1 POUCHCLOTH282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81032-422LOLA VAGINAL ITCH RELIEF WIPES (PRAMOXINE HYDROCHLORIDE) CLOTH [ALYK, INC.]2Legacy NDC, 1 package rows20210603_be77387d-5f48-4592-e053-2a95a90a384d.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81032-42281032-422-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
LONICERA JAPONICA FLOWER4465L2WS4YIACT
SODIUM BENZOATEOJ245FE5EUIACT
TOCOPHEROLR0ZB2556P8IACT
APPLE CIDER VINEGAR0UE22Q87VCIACT
WATER059QF0KO0RIACT
OAT BRANKQX236OK4UIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
GLUCONIC ACIDR4R8J0Q44BIACT
GLYCERINPDC6A3C0OXIACT
LONICERA CAPRIFOLIUM FLOWER5N1WD9784UIACT
POLYGLYCERYL-4 CAPRATE3N873UN885IACT
POLYGLYCERYL-6 CAPRYLATEDGV8R54VG7IACT
LEVOMENOL24WE03BX2TIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT

Source Document#

Source XML

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
bf671909-2956-10ba-e053-2995a90a50d4be77387d-5f48-4592-e053-2a95a90a384d2021-04-07WarningsExact identifier
spl id: bf671909-2956-10ba-e053-2995a90a50d4
spl set id: be77387d-5f48-4592-e053-2a95a90a384d

Reported adverse events (FAERS/openFDA)#

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