NDC 0113-7142 Basic Care Vagicaine

Benzocaine, Resorcinol

NDC Product Code 0113-7142

NDC Code: 0113-7142

Proprietary Name: Basic Care Vagicaine Additional informationCallout TooltipWhat 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: Benzocaine, Resorcinol Additional informationCallout TooltipWhat 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.


Code Structure
  • 0113 - L. Perrigo Company
    • 0113-7142 - Basic Care Vagicaine

NDC 0113-7142-21

Package Description: 3 TUBE in 1 CARTON > 28 g in 1 TUBE

NDC Product Information

Basic Care Vagicaine with NDC 0113-7142 is a a human over the counter drug product labeled by L. Perrigo Company. The generic name of Basic Care Vagicaine is benzocaine, resorcinol. The product's dosage form is cream and is administered via topical form.

Labeler Name: L. Perrigo Company

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Basic Care Vagicaine Active Ingredient(s)

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

  • BENZOCAINE 20 g/100g
  • RESORCINOL 3 g/100g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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)
  • CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CHOLECALCIFEROL (UNII: 1C6V77QF41)
  • CORN OIL (UNII: 8470G57WFM)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • ISOPROPYL STEARATE (UNII: 43253ZW1MZ)
  • LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • SODIUM SULFITE (UNII: VTK01UQK3G)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TRISODIUM HEDTA (UNII: K3E0U7O8KI)
  • TROLAMINE (UNII: 9O3K93S3TK)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: L. Perrigo Company
Labeler Code: 0113
FDA Application Number: part348 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-07-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Basic Care Vagicaine Product Label Images

Basic Care Vagicaine 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 Ingredients

Benzocaine 20%Resorcinol 3%

Purpose

External analgesic

Use

Temporarily relieves itching

Warnings

For external use only

When Using This Product

Avoid contact with the eyes

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 Apply

Over large areas of the body

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

Adults and children 12 years and olderapply a fingertip amount (approximately 1-inch strip) to the affected area not more than 3 to 4 times daily. Clean nozzle of tube by wiping thoroughly before replacing cap. Keep cap tightly closed between uses.children under 12 yearsask a doctor

Other Information

  • •store at 20-25°C (68-77°F)

Inactive Ingredients

Aloe barbadensis leaf juice, carbomer homopolymer type C, cetyl alcohol, cholecalciferol, corn (zea mays) oil, fragrance, glyceryl monostearate, isopropyl myristate, isopropyl palmitate, isopropyl stearate, lanolin alcohol, methylparaben, mineral oil, PEG-100 stearate, propylene glycol, purified water, retinyl palmitate, sodium sulfite anhydrous, tocopheryl acetate, trisodium HEDTA, trolamine

* Please review the disclaimer below.

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