NDC 41250-985 Meijer Skin Relieving Moisturizing

Dimethicone

NDC Product Code 41250-985

NDC Product Information

Meijer Skin Relieving Moisturizing with NDC 41250-985 is a a human over the counter drug product labeled by Meijer Distribution, Inc. The generic name of Meijer Skin Relieving Moisturizing is dimethicone. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Meijer Distribution, 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.

Meijer Skin Relieving Moisturizing 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.

  • DIMETHICONE 12 mg/mL

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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • DISTEARYLDIMONIUM (UNII: 251IW5I21C)
  • OATMEAL (UNII: 8PI54V663Y)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • OAT KERNEL OIL (UNII: 3UVP41R77R)
  • STEARETH-20 (UNII: L0Q8IK9E08)
  • OAT (UNII: Z6J799EAJK)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)

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: Meijer Distribution, Inc
Labeler Code: 41250
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: 07-23-2019 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.

Meijer Skin Relieving Moisturizing Product Label Images

Meijer Skin Relieving Moisturizing 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

Dimethicone 1.2%

Purpose

Skin Protectant

Uses

  • Helps prevent and temporarily protects chafed, chapped or cracked skinhelps protect from the drying effects of wind and cold weather

Warnings

For external use only

Otc - When Using

When using this product • do not get into eyes

Otc - Do Not Use

  • Do not use ondeep or puncture woundsanimal bitesserious burns

Otc - Ask Doctor

  • Stop use and ask a doctor if
  • Condition worsenssymptoms last more than seven days or clear up and occur again within a few days

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.

Directions

  • Apply as needed to hands or body when skin feels dry or irritated

Other

Other Information • may stain some fabrics

Inactive Ingredients

Water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, avena sativa (oat) kernel flour, benzyl alcohol, avena sativa (oat) kernel oil, steareth-20, avena sativa (oat) kernel extract, butyrospermum parkii (shea) butter, potassium sorbate, sodium chloride

* Please review the disclaimer below.

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