NDC 73302-205 Mederma Scar Cream

Avobenzone, Octocrylene, And Oxybenzone

NDC Product Code 73302-205

NDC 73302-205-20

Package Description: 1 TUBE in 1 CARTON > 20 g in 1 TUBE

NDC Product Information

Mederma Scar Cream with NDC 73302-205 is a a human over the counter drug product labeled by Hra Pharma America, Inc.. The generic name of Mederma Scar Cream is avobenzone, octocrylene, and oxybenzone. The product's dosage form is cream and is administered via topical form.

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.

Mederma 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.


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)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
  • ALCOHOL (UNII: 3K9958V90M)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • ONION (UNII: 492225Q21H)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
  • SQUALANE (UNII: GW89575KF9)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • ETHYLPARABEN (UNII: 14255EXE39)
  • CERAMIDE NP (UNII: 4370DF050B)
  • 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: Hra Pharma America, Inc.
Labeler Code: 73302
FDA Application Number: part352 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: 08-20-2021 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.

Mederma Scar Cream Product Label Images

Mederma 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 INGREDIENTSPURPOSEAvobenzone 3%, Octocrylene 10%, Oxybenzone 6%Sunscreen

Indications & Usage

USES • Helps prevent sunburn

Warnings

WARNINGS • Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. • For external use only

Otc - Do Not Use

Do not use on • Damaged or broken skin

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.

Otc - When Using

When using this product • Keep out of eyes • Rinse with water to remove

Otc - Stop Use

Stop use and ask a doctor • If rash occurs

Dosage & Administration

DIRECTIONS • For sunscreen use: Apply liberally 15 minutes before sun exposure • Reapply at least every 2 hours • Children under 6 months: Ask a doctor • Use a water-resistant sunscreen if swimming or sweating

Storage And Handling

OTHER INFORMATION • Store at room temperature • Protect this product from excessive heat and direct sun

Inactive Ingredient

INACTIVE INGREDIENTS • Water, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Alcohol, Caprylic/Capric Triglyceride, Hydrogenated Phosphatidylcholine, Panthenol, Glycerin, Pentylene Glycol, Phenoxyethanol, Butyrospermum Parkii (Shea) Butter, Allium Cepa (Onion) Bulb Extract, Ammonium Acryloyldimethyltaurate/VP Copolymer, Fragrance, Squalane, Methylparaben, Xanthan Gum, Propylparaben, Disodium EDTA, Sodium Hyaluronate, Ethylparaben, Ceramide NP, Tocopherol.

Otc - Questions

QUESTIONS OR COMMENTS? • For more information call 1-833-426-6733 or visit www.mederma.com

* Please review the disclaimer below.