NDC 69693-815 Baby Anti Monkey Butt Diaper Rash

Zinc Oxide, Ferric Oxide Red

  1. Labeler Index
  2. Clarion Brands, Llc
  3. NDC: 69693-815 Baby Anti Monkey Butt Diaper Rash

NDC Product Code 69693-815

NDC CODE: 69693-815

Proprietary Name: Baby Anti Monkey Butt Diaper Rash 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: Zinc Oxide, Ferric Oxide Red 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

  • 69693 - Clarion Brands, Llc
    • 69693-815 - Baby Anti Monkey Butt Diaper Rash

NDC 69693-815-06

Package Description: 170 g in 1 BOTTLE

NDC Product Information

Baby Anti Monkey Butt Diaper Rash with NDC 69693-815 is a a human over the counter drug product labeled by Clarion Brands, Llc. The generic name of Baby Anti Monkey Butt Diaper Rash is zinc oxide, ferric oxide red. The product's dosage form is powder and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1368904 and 1489926.

Dosage Form: Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

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.

Baby Anti Monkey Butt Diaper Rash 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.
  • STARCH, CORN (UNII: O8232NY3SJ)
  • TRICALCIUM PHOSPHATE (UNII: K4C08XP666)

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: Clarion Brands, Llc
Labeler Code: 69693
FDA Application Number: part347 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: 01-01-2016 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.

Baby Anti Monkey Butt Diaper Rash Product Label Images

Baby Anti Monkey Butt Diaper Rash 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

Calamine Powder 8.0%

Purpose

Skin Protectant

Uses

  • Helps treat and prevent diaper rashprotects chafed skin and minor skin irritations due to diaper rashhelps protect from wetness

Warnings

For external use only

When Using This Product

  • Avoid contact with eyesdo not use on broken skinkeep powder away from child's face to avoid inhalation, which can cause breathing problems

Stop Use And Ask A Doctor If

  • Condition worsenssymptoms last more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 2 years and older: apply freely up to 3 or 4 times daily. For best results, dry skin thoroughly before applying.babies: change wet and soiled diaper promptly, cleanse the diaper area and allow to dry. Apply powder liberally as often as necessary, with each diaper change, especially at bedtime, or anytime when exposure to wet diapers may be prolonged. Apply powder close to the body away from child's face. Carefully shake the powder into the diaper or into the hand and apply to the diaper area.

Inactive Ingredients

Cornstarch, fragrance, tricalciumphosphate

Questions?

Call 1-844-426-8465

* Please review the disclaimer below.