NDC 81032-422 Lola Vaginal Itch Relief Wipes

Pramoxine Hydrochloride

NDC Product Code 81032-422

NDC 81032-422-28

Package Description: 28 L in 1 POUCH

NDC Product Information

Lola Vaginal Itch Relief Wipes with NDC 81032-422 is a a human over the counter drug product labeled by Alyk, Inc.. The generic name of Lola Vaginal Itch Relief Wipes is pramoxine hydrochloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Alyk, Inc.

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Lola Vaginal Itch Relief Wipes Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PRAMOXINE HYDROCHLORIDE 10 mg/.00001L

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • APPLE CIDER VINEGAR (UNII: 0UE22Q87VC)
  • WATER (UNII: 059QF0KO0R)
  • OAT BRAN (UNII: KQX236OK4U)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • GLUCONIC ACID (UNII: R4R8J0Q44B)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)
  • LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
  • POLYGLYCERYL-4 CAPRATE (UNII: 3N873UN885)
  • POLYGLYCERYL-6 CAPRYLATE (UNII: DGV8R54VG7)
  • TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
  • LEVOMENOL (UNII: 24WE03BX2T)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Alyk, Inc.
Labeler Code: 81032
FDA Application Number: part348 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-31-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Lola Vaginal Itch Relief Wipes Product Label Images

Lola Vaginal Itch Relief Wipes Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Pramoxine hydrochloride 1% (w/w)

Purpose

External analgesic

Use

Temporarily relieves itching

Warnings

For external use onlyAvoid contact with eyes

Stop Use

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

  • 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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

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

Inactive Ingredient(S)

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

* Please review the disclaimer below.