NDC 59088-685 Cvs Maximum Strength Feminine Anti-itch Wipes

Pramoxine Hydrochloride

NDC Product Code 59088-685

NDC Code: 59088-685

Proprietary Name: Cvs Maximum Strength Feminine Anti-itch Wipes What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Pramoxine Hydrochloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 59088 - Puretek Corporation
    • 59088-685 - Cvs Maximum Strength Feminine Anti-itch Wipes

NDC 59088-685-52

Package Description: 85 g in 1 PACKAGE

NDC Product Information

Cvs Maximum Strength Feminine Anti-itch Wipes with NDC 59088-685 is a a human over the counter drug product labeled by Puretek Corporation. The generic name of Cvs Maximum Strength Feminine Anti-itch Wipes is pramoxine hydrochloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Puretek Corporation

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.

Cvs Maximum Strength Feminine Anti-itch 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/g

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)
  • WATER (UNII: 059QF0KO0R)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • DEHYDROACETIC ACID (UNII: 2KAG279R6R)
  • DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLIHEXANIDE (UNII: 322U039GMF)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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: Puretek Corporation
Labeler Code: 59088
FDA Application Number: part346 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 06-03-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Cvs Maximum Strength Feminine Anti-itch Wipes Product Label Images

Cvs Maximum Strength Feminine Anti-itch 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

Drug Facts

Active ingredientPramoxine Hydrochloride 1%

Purpose

Topical Analgesic

Uses

For the temporary relief of personal discomfort

Warnings

For external use only

Stop Use And Ask A Doctor If

  • Conditions worsenssymptoms persist for more than 7 days or clear up and occur again within a few days.

Keep Out Of Reach Of Children.

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

Directions

  • Remove cloth from container, close container unfold cloth and gently wipe area from front to backuse only once, then throw used cloth away do not flush, discard in trash containeradults and children 12 years of age and older: apply to affected area dailychildren under 12 years of age: consult a doctor before using

Other Information

  • Store at controlled room temperature 20°-25°C (68°-77°F)

Inactive Ingredients

Aloe Barbadensis Leaf juice, Aqua (Purified Water), Benzoic Acid, Citric Acid, Dehydroacetic Acid, Disodium Cocoamphodiacetate, Fragrance, Glycerin, Phenoxyethanol, Polyaminopropyl Biguanide, Polysorbate 20, Sodium Hydroxide, Tocopheryl Acetate (Vitamin E).

* Please review the disclaimer below.

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