NDC 55910-158 Dg Health Feminine Anti-itch

Benzocaine Resorcinol

NDC Product Code 55910-158

NDC Product Information

Dg Health Feminine Anti-itch with NDC 55910-158 is a a human over the counter drug product labeled by Dolgencorp, Llc. The generic name of Dg Health Feminine Anti-itch is benzocaine resorcinol. The product's dosage form is cream and is administered via topical form.

Labeler Name: Dolgencorp, Llc

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 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.

Dg Health Feminine Anti-itch 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.

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

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.

  • WATER (UNII: 059QF0KO0R)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • TRISODIUM HEDTA MONOHYDRATE (UNII: 463A7RIB6K)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CHOLECALCIFEROL (UNII: 1C6V77QF41)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SULFITE ION (UNII: 15744271E9)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • LANOLIN (UNII: 7EV65EAW6H)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ISOPROPYL STEARATE (UNII: 43253ZW1MZ)

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: Dolgencorp, Llc
Labeler Code: 55910
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: 06-13-2019 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.

Dg Health Feminine Anti-itch Product Label Images

Dg Health Feminine Anti-itch 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 analgesicExternal analgesic

Use

Temporarily relieves itching

Warnings

For external use onlyAvoid contact with 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 daysDo not apply over large areas of the body

Do Not Use

Do not apply over large areas of the bodyDo not use if allergic to any of the ingredients

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 older: Apply a fingertip amount (approximately 1-inch strip) to 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 years of age: Consult a doctor

Inactive Ingredients

Aloe barbadensis leaf extract, carbomer, cetyl alcohol, cholecalciferol, glyceryl stearate, isopropyl myristate, isopropyl palmitate, isopropyl stearate, lanolin, methylparaben, mineral oil, PEG-100 stearate, propylene glycol, retinyl palmitate, sodium hydroxide, sodium sulfite, tocopheryl acetate, trisodium HEDTA, water

* Please review the disclaimer below.

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