NDC 69842-588 Anti-itch Medicated Maximum Strength

Benzocaine And Resorcinol

NDC Product Code 69842-588

NDC CODE: 69842-588

Proprietary Name: Anti-itch Medicated Maximum Strength 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: Benzocaine And Resorcinol 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.

Product Characteristics

Color(s):
WHITE (C48325)

NDC Code Structure

  • 69842 - Cvs Health
    • 69842-588 - Anti-itch Medicated Maximum Strength

NDC 69842-588-28

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

NDC Product Information

Anti-itch Medicated Maximum Strength with NDC 69842-588 is a a human over the counter drug product labeled by Cvs Health. The generic name of Anti-itch Medicated Maximum Strength is benzocaine and resorcinol. The product's dosage form is cream and is administered via topical form.

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.

Anti-itch Medicated Maximum Strength 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.


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)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • CORN OIL (UNII: 8470G57WFM)
  • CHOLECALCIFEROL (UNII: 1C6V77QF41)
  • LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • ISOPROPYL STEARATE (UNII: 43253ZW1MZ)
  • SODIUM SULFITE (UNII: VTK01UQK3G)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • TRISODIUM HEDTA (UNII: K3E0U7O8KI)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)

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: Cvs Health
Labeler Code: 69842
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: 09-30-2021 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.

Anti-itch Medicated Maximum Strength 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

Other

Drug Facts

Active Ingredient

Benzocaine 20%Resorcinol 3%

Purpose

External analgesicExternal analgesic

Use

Temporarily relieves itching

Warnings

For external use onlyAllergy AllertDo not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other –caine anesthetics.Avoid contact with eyesin case of contact rinse thoroughly and immediately with water.

Stop Use And Ask Doctor If

Condition worsens, or if symptoms 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

Adults and children 12 years and olderApply a finger tip amount (approxiamtely a 1 inch strip) to the affected areas not more than 3 to 4 times dailyChildren under 12 years ask a doctor

Other Information:

Questions?

Inactive Ingredients

Water, Mineral Oil, Cetyl Alcohol, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Isopropyl Palmitate, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Retinyl Palmitate, Zea Mays (Corn) Oil, Cholecalciferol, Lanolin Alcohol, Fragrance, Methylparaben, Carbomer, Isopropyl Myristate, Isopropyl Stearate, Sodium Sulfite, Triethanolamine, Trisodium EDTA, Maltodextrin

* Please review the disclaimer below.