NDC 73318-4180 Body Seal Ultra Reparing

Oatmeal

NDC Product Code 73318-4180

NDC 73318-4180-2

Package Description: 1 TUBE in 1 CARTON > 180 mL in 1 TUBE (73318-4180-1)

NDC Product Information

Body Seal Ultra Reparing with NDC 73318-4180 is a a human over the counter drug product labeled by Skin Ps Brands. The generic name of Body Seal Ultra Reparing is oatmeal. The product's dosage form is cream and is administered via topical form.

Labeler Name: Skin Ps Brands

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.

Body Seal Ultra Reparing 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.

  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • WATER (UNII: 059QF0KO0R)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • SUNFLOWER SEED OIL GLYCERETH-8 ESTERS (UNII: 358X17CAT0)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • RICE BRAN OIL (UNII: LZO6K1506A)
  • OAT KERNEL OIL (UNII: 3UVP41R77R)
  • POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
  • CARBOMER 980 (UNII: 4Q93RCW27E)
  • GRAPE SEED OIL (UNII: 930MLC8XGG)
  • HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
  • BARLEY (UNII: 5PWM7YLI7R)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)
  • SANDALWOOD (UNII: 3641YW25N2)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • HYDROGENATED SOYBEAN PHOSPHATIDYLCHOLINE (UNII: QHQ97HF0PY)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • SQUALANE (UNII: GW89575KF9)
  • CERAMIDE NP (UNII: 4370DF050B)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)

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.
  • 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: Skin Ps Brands
Labeler Code: 73318
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: 08-25-2020 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: 12-31-2021 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.

Body Seal Ultra Reparing Product Label Images

Body Seal Ultra Reparing 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 Ingredient

Colloidal Oatmeal 1.0%

Purpose

Skin Protectant

Uses

  • Temporarily protects and helps relieve minor skin irritations and itching due to eczema rashes

Warnings

For External Use Only

When Using This Product

Avoid contact with eyes

Stop Use And Ask A Doctor If

  • Condition worsenssymptom 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 directly to affected areas of skin

Other Information

Store in a cool, dry place

Inactive Ingredients

Dimethicone,Water, Dimethicone, Butylene Glycol, Glycerin, Cetyl Alcohol, Glyceryl Stearate SE, Helianthus Annuus (Sunflower) Seed Oil, Niacinamide, Oryza Sativa (Rice) Bran Oil, Avena Sativa (Oat) Kernel Flour, Potassium Cetyl Phosphate, 1,2-Hexandiol, Caprylyl Glycol, Aluminum Starch Octenylsuccinate, Carbomer, Vitis Vinifera (Grape) Seed Oil, Hydrogenated Palm Glycerides, Aminomethyl Propanol, Sodium PCA, Hordeum Distichon (Barley) Extract, Panthenol, Tocopheryl Acetate, Phellodendron Amurense Bark Extract, Santalum Album (Sandalwood) Extract, Caprylic/Capric Triglyceride, Hydrogenated Phosphatidylcholine, Dipotassium Glycyrrhizate, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea ) Butter, Pentylene Glycol, Squalane, Ceramide NP, Sodium Hyaluronate.

* Please review the disclaimer below.