NDC 71521-407 Xzm Kids Care

Colloidal Oatmeal

NDC Product Code 71521-407

NDC 71521-407-30

Package Description: 1 BOTTLE, PUMP in 1 BOX > 30 g in 1 BOTTLE, PUMP

NDC Product Information

Xzm Kids Care with NDC 71521-407 is a a human over the counter drug product labeled by Lavior Inc. The generic name of Xzm Kids Care is colloidal oatmeal. The product's dosage form is cream and is administered via topical form.

Labeler Name: Lavior Inc

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.

Xzm Kids Care 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/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.

  • DITTRICHIA VISCOSA WHOLE (UNII: 3SYW69FH88)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
  • .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM GLUCONATE (UNII: R6Q3791S76)

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: Lavior Inc
Labeler Code: 71521
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: 04-02-2019 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.

Xzm Kids Care 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

Colloidal Oatmeal 1% ............... Skin Protectant

Purpose

Skin protectant

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to:

rashes

eczema

Warnings

For external use onlyWhen using this productavoid contact with eyesStop use and ask a doctor ifcondition worsens

symptoms 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 a thin layer 1 to 2 times daily, or as directed by a doctor

For babies under 2 months of age: ask a doctor

Other Information

For mild to moderate eczema.

Store at room temperature.

Inactive Ingredients

Aqua, Glycerin, Inula Viscosa Flower/Leaf/Stem Extract, Xanthan Gum, Glyceryl Stearate Citrate, Aloe Barbadensis Leaf Juice, Propanediol-1,3, Cetyl Alcohol, Sodium Benzoate, Potassium Sorbate, Biosaccharide Gum-1, Tocopheryl Acetate (Vitamin E), Sodium Gluconate, Citric Acid.

Questions?

Call toll free 1-844-474-2552 or visit lavior.com

* Please review the disclaimer below.

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