NDC 72982-1905 Scar Cream

Allantoin Cream

NDC Product Code 72982-1905

NDC Product Information

Scar Cream with NDC 72982-1905 is a a human over the counter drug product labeled by Everyday Medical Llc. The generic name of Scar Cream is allantoin cream. The product's dosage form is cream and is administered via topical form.

Labeler Name: Everyday Medical Llc

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.

Scar 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.

  • ALLANTOIN 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.

  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
  • WATER (UNII: 059QF0KO0R)
  • CLOVE OIL (UNII: 578389D6D0)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ONION (UNII: 492225Q21H)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
  • MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
  • PHYLLANTHUS EMBLICA WHOLE (UNII: 9B45E1E94Z)
  • TAMARIND (UNII: 2U9H66X7VX)
  • CENTELLA ASIATICA (UNII: 7M867G6T1U)

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: Everyday Medical Llc
Labeler Code: 72982
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: 07-08-2019 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: 12-31-2020 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.

Scar Cream Product Label Images

Scar 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 IngredientsAllantoin 1% Skin Protectant

Otc - Purpose

Skin protectant

Indications & Usage

Temporarily protects and helps relieve chapped or cracked skin

Warnings

  • WarningsFor external use onlyDo not get into eyesStop use and ask a doctor ifcondition worsensSymptoms last more than 7 days or clear up and occur again within a few daysDo not use on deep or punctured wounds, animal bites, serious burns

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away​

Dosage & Administration

Apply as needed

Inactive Ingredient

CENTELLA ASIATICACYCLOMETHICONE 5

PHENYL TRIMETHICONE

ALKYL (C12-15) BENZOATE

CARBOMER INTERPOLYMER TYPE A (55000 CPS)

WATER

CLOVE OIL

ALOE VERA LEAF

CETYL ALCOHOL

ONION

GLYCERIN

STEARIC ACID

EDETIC ACID

GLYCERYL STEARATE/PEG-100 STEARATE

MELALEUCA ALTERNIFOLIA LEAF

BUTYLATED HYDROXYTOLUENE

SODIUM HYDROXIDE

CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE

PHYLLANTHUS EMBLICA WHOLE

TAMARIND

CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE​

* Please review the disclaimer below.

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