NDC 72289-0006 Sandawha Moisturizing Baby

Glycerin

NDC Product Code 72289-0006

NDC Product Information

Sandawha Moisturizing Baby with NDC 72289-0006 is a a human over the counter drug product labeled by Skincure Inc. The generic name of Sandawha Moisturizing Baby is glycerin. The product's dosage form is cream and is administered via topical form.

Labeler Name: Skincure 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 Additional informationCallout TooltipWhat 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.


Sandawha Moisturizing Baby Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • GLYCERIN 3.1545 g/100g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • PANTHENOL (UNII: WV9CM0O67Z)
  • SQUALENE (UNII: 7QWM220FJH)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Skincure Inc
Labeler Code: 72289
FDA Application Number: part347 Additional informationCallout TooltipWhat 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. Additional informationCallout TooltipWhat 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: 02-24-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Sandawha Moisturizing Baby Product Label Images

Sandawha Moisturizing Baby 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

Glycerin

Inactive Ingredient

Camellia Japonica Flower Extract

Caprylic/Capric Triglyceride

Glycerin

Water(Aqua)

Pentylene Glycol

Camellia Japonica Seed Oil

Propanediol

Hydrogenated Palm Kernel Oil

Phosphatidylcholine

Phytosteryl Macadamiate

Butyrospermum Parkii (Shea) Butter

Mangifera Indica (Mango) Seed Butter

Xanthan Gum

Panthenol

Camellia Sinensis Leaf Extract

Chamomilla Recutita (Matricaria) Leaf Extract

Thujopsis Dolabrata Branch Extract

Sorbitan Caprylate

Arginine

Squalane

Trehalose

Magnolia Kobus Bark Extract

Salix Alba (Willow) Bark Extract

Dipotassium Glycyrrhizate

Centella Asiatica Extract

Dimethyl Sulfone

Hizikia Fusiforme Extract

Glycyrrhiza Glabra (Licorice) Root Extract

Yeast Beta-Glucan

Levulinic Acid

Betaine

Houttuynia Cordata Extract

Portulaca Oleracea Extract

Hyaluronic Acid

Aloe Barbadensis Leaf Extract

Olea Europaea (Olive) Fruit Oil

Citrus Unshiu Peel Extract

Opuntia Ficus-Indica Fruit Extract

Polygonum Cuspidatum Root Extract

Scutellaria Baicalensis Root Extract

Vitis Vinifera (Grape) Skin Extract

Tocopherol

Pyrus Malus (Apple) Fruit Extract

Rosmarinus Officinalis (Rosemary) Leaf Extract

Silybum Marianum Extract

Vaccinium Angustifolium (Blueberry) Fruit Extract

Bioflavonoids

Bisabolol

Rosa Canina Fruit Oil

Brassica Oleracea Italica (Broccoli) Extract

Linoleic Acid

Rutin

Astaxanthin

Quercetin

Aniba Rosodora (Rosewood) Wood Oil

Jasminum Sambac (Jasmine) Flower Extract

Lavandula Angustifolia (Lavender) Oil

Rosmarinus Officinalis (Rosemary) Leaf Oil

Otc - Purpose

Suitable for delicate baby's skinsoothes and protects sensitive skin

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

Gently massage into skin as often as needed

Warnings

For external use onlydo not use if sensitive to any of the ingredientsdiscontinue use if signs of irritation or rash appearif irritation or rash persists, contact a doctor

Dosage & Administration

For external use only

* Please review the disclaimer below.

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