NDC 72289-0004 Sandawha Soft Baby Wash

Glycerin

NDC Product Code 72289-0004

NDC Product Information

Sandawha Soft Baby Wash with NDC 72289-0004 is a a human over the counter drug product labeled by Skincure Inc. The generic name of Sandawha Soft Baby Wash 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 Soft Baby Wash 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 1.9345 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)
  • CITRIC ACID ACETATE (UNII: DSO12WL7AU)
  • 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 Soft Baby Wash Product Label Images

Sandawha Soft Baby Wash 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

Disodium Cocoamphodiacetate

Lauryl Glucoside

Sodium Lauroyl Glutamate

Glycerin

Pentylene Glycol

Citric Acid

Sorbitan Caprylate

Panthenol

Propanediol

Trehalose

Water(Aqua)

Centella Asiatica Extract

Dipotassium Glycyrrhizate

Dimethyl Sulfone

Portulaca Oleracea Extract

Hizikia Fusiforme Extract

Glycyrrhiza Glabra (Licorice) Root Extract

Houttuynia Cordata Extract

Coptis Japonica Root Extract

Yeast Beta-Glucan

Betaine

Hyaluronic Acid

Aloe Barbadensis Leaf Extract

Levulinic Acid

Olea Europaea (Olive) Fruit Oil

Camellia Sinensis Leaf Extract

Opuntia Ficus-Indica Fruit Extract

Polygonum Cuspidatum Root Extract

Scutellaria Baicalensis Root Extract

Camellia Japonica Seed Oil

Rosmarinus Officinalis (Rosemary) Leaf Extract

Tocopherol

Bioflavonoids

Chamomilla Recutita (Matricaria) Leaf Extract

Bisabolol

Rosa Canina Fruit Oil

Brassica Oleracea Italica (Broccoli) Extract

Michelia Alba Flower Oil

Rose Flower Oil

Cananga Odorata Flower Oil

Otc - Purpose

Protect the skin from dryness and irritation while leaving baby's skin clean and fresh

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

Wet baby's skin and hair with warm water. Gently massage over entire body and scalp, then rinse thoroughly.

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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