NDC 73517-426 Pipette Diaper Rash

Colloidal Oatmeal

NDC Product Code 73517-426

NDC 73517-426-01

Package Description: 1 TUBE in 1 CARTON > 177 mL in 1 TUBE

NDC 73517-426-02

Package Description: 30 mL in 1 TUBE

NDC Product Information

Pipette Diaper Rash with NDC 73517-426 is a a human over the counter drug product labeled by Amyris, Inc. The generic name of Pipette Diaper Rash is colloidal oatmeal. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Amyris, Inc

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Pipette 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.

  • OATMEAL 1 g/100mL

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)
  • SQUALANE (UNII: GW89575KF9)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SUNFLOWER SEED OIL GLYCERETH-8 ESTERS (UNII: 358X17CAT0)
  • 12-HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
  • SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • CERAMIDE NP (UNII: 4370DF050B)
  • HEXASODIUM PHYTATE (UNII: ZBX50UG81V)
  • TOCOPHEROL (UNII: R0ZB2556P8)

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: Amyris, Inc
Labeler Code: 73517
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: 02-01-2021 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 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.

Pipette Diaper Rash Product Label Images

Pipette 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

Colloidal Oatmeal 1%

Purpose

Skin Protectant

Uses

  • Temporarily protects and helps relieve minor skin irritation and itching due to eczemarashes

Warnings

  • For external use only

When Using This Product

  • Do not get into eyes

Stop Use And Aks 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

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply as needed

Other Information

Protect this product from excessive heat and direct sunlight

Inactive Ingredients

Water, Squalane, Caprylic/Capric Triglyceride, Glycerin, Hydrogenated Sunflower Seed Oil Polyglyceryl-3Esters, Hydroxystearic/Linolenic/Oleic Polyglycerides, Butyrospermum Parkii (Shea ) Butter, Jojoba Esters.Cetearyl Alcohol, Hydrogenated Sunflower Seed Oil Glyceryl Esters, Propanediol, Hydroxyacetophenone, Sodium Stearoyl Lactylate, XanthanGum, Citric Acid, Ethylhexylglycerin, Potassium Sorbate, Ceramide NP, Sodium Phytate, Tocopherol.

* Please review the disclaimer below.