NDC 72570-125 Diaperene Adult

Menthol, Zinc Oxide

NDC Product Code 72570-125

NDC 72570-125-16

Package Description: 454 g in 1 CONTAINER

NDC Product Information

Diaperene Adult with NDC 72570-125 is a a human over the counter drug product labeled by Delsam Pharma Llc. The generic name of Diaperene Adult is menthol, zinc oxide. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Delsam Pharma Llc

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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.

Diaperene Adult 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.

  • MENTHOL, UNSPECIFIED FORM .44 g/100g
  • ZINC OXIDE 20.6 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.

  • LANOLIN (UNII: 7EV65EAW6H)
  • WHITE PETROLATUM (UNII: B6E5W8RQJ4)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

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: Delsam Pharma Llc
Labeler Code: 72570
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: 04-01-2021 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.

Diaperene Adult Product Label Images

Diaperene Adult 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

Menthol 0.44%Zinc Oxide 20.6%.

Purpose

External Analgesic / Anti-itchSkin Protectant, Anorectal Astringent

Uses

• Protects and Helps Heal Skin Irritations From • Incontinence of Urine or Diarrhea • Feeding Tube Site Leakage • Diaper Rash • Wound Drainage • Minor Cuts & Scrapes • Bedsores • Burns/ Irradiated Skin • Temporarily Relieves Discomfort & Itching

Warnings

For external use only. Not for deep or puncture wounds. Avoid contact with eyes. In case of accidental ingestion contact a physician or poison control center immediately. If condition worsens or does not improve within 7 days, consult a doctor.When using this product• Certain persons can develop allergic reactions to ingredients in this product. • Do not put this product into the rectum by using fingers or any mechanical device or applicator. • Do not exceed the recommended daily dosage unless directed by a doctor.Stop use and ask a doctor if • Bleeding occurs  • Symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase

Otc - Keep Out Of Reach Of Children

• Keep out of reach of children

Directions

Cleanse skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply a thin layer of Diaperene Adult Ointment to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection.

Other Information

• Store between: 15-30°C (59-86°F)

Inactive Ingredients

Lanolin, White soft paraffin, Light liquid paraffin, Calamine, Glycerin, Propylene glycol

* Please review the disclaimer below.