NDC 76772-026 Bath And Beauty Diabetics Foot Cream

Dimethicone, Petrolatum

NDC Product Code 76772-026

NDC CODE: 76772-026

Proprietary Name: Bath And Beauty Diabetics Foot Cream 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: Dimethicone, Petrolatum 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

  • 76772 - Tsm Ithalat Ihracat Sanayi Ve Dis Ticaret Limited Sirketi

NDC 76772-026-11

Package Description: 113 g in 1 TUBE

NDC Product Information

Bath And Beauty Diabetics Foot Cream with NDC 76772-026 is a a human over the counter drug product labeled by Tsm Ithalat Ihracat Sanayi Ve Dis Ticaret Limited Sirketi. The generic name of Bath And Beauty Diabetics Foot Cream is dimethicone, petrolatum. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Tsm Ithalat Ihracat Sanayi Ve Dis Ticaret Limited Sirketi

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.

Bath And Beauty Diabetics Foot Cream 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.

  • PETROLATUM 30 g/100g
  • DIMETHICONE 1 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.

  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • C13-16 ISOPARAFFIN (UNII: LED42LZG6O)
  • LAURETH-7 (UNII: Z95S6G8201)
  • POLYQUATERNIUM-22 (4500 MPA.S) (UNII: H3W1D31JAR)
  • .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • LAURETH-25 (UNII: RPD53041LR)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)

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: Tsm Ithalat Ihracat Sanayi Ve Dis Ticaret Limited Sirketi
Labeler Code: 76772
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: 03-10-2021 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.

Bath And Beauty Diabetics Foot Cream Product Label Images

Bath And Beauty Diabetics Foot Cream 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

Otc - Active Ingredient

Active Ingredient PurposeDimethicone 1% ...... Skin ProtectantPetrolatum 30%........Skin Protectant

Otc - Purpose

Skin protectant

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Indications & Usage

Use help prevent and temporarily protets chafed, chapped, or cracked skin.

Warnings

Warnings For external use only.

When Using This Product

Avoid contact with eyes. In case of eye contact, flush with water.

Do Not Use On

Do not use ondeep or puncture wounds


animal bites


serious burns

Dosage & Administration

Directions  apply liberally as often as needed.

Other Safety Information

Other information Store at room temperature.

Inactive Ingredient

Inactive Ingredients Water, Ceterayl Alcohol, PEG-100 Stearate, Glycerin, Glyceryl Stearate, Polyquaternium-22, C13-16 Isoparaffin Laureth-25,DMDM Hydantoin, Carbomer, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Panthenol, Tocopheryl Acetate

* Please review the disclaimer below.