NDC 11673-353 Up And Up Intensive Healing

Hydrocortisone

NDC Product Code 11673-353

NDC Code: 11673-353

Proprietary Name: Up And Up Intensive Healing Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Hydrocortisone Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 11673 - Target Corporation
    • 11673-353 - Up And Up Intensive Healing

NDC 11673-353-25

Package Description: 1 TUBE in 1 CARTON > 99 g in 1 TUBE

NDC Product Information

Up And Up Intensive Healing with NDC 11673-353 is a a human over the counter drug product labeled by Target Corporation. The generic name of Up And Up Intensive Healing is hydrocortisone. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Target Corporation

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 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.


Up And Up Intensive Healing 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.

  • HYDROCORTISONE 1 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • OAT (UNII: Z6J799EAJK)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ICODEXTRIN (UNII: 2NX48Z0A9G)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • ISOHEXADECANE (UNII: 918X1OUF1E)
  • MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • METHYL GLUCETH-20 (UNII: J3QD0LD11P)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • GINGER (UNII: C5529G5JPQ)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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: Target Corporation
Labeler Code: 11673
FDA Application Number: part348 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: 01-23-2019 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.

Up And Up Intensive Healing Product Label Images

Up And Up Intensive Healing 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

Hydrocortisone 1%

Purpose

Anti-itch

Uses

  • •temporarily relieves itching associated with minor skin irritations, rashes, and inflammation due to eczema •other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Do Not Use

For the treatment of diaper rash. Consult a doctor.

When Using This Product

  • •avoid contact with eyes •do not use more than directed unless told to do so by a doctor

Stop Use And Ask A Doctor If

Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

  • •adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily •children under 2 years of age: ask a doctor

Other Information

  • •store at 20-25°C (68-77°F) •contents filled by weight, not volume

Inactive Ingredients

Aloe barbadensis leaf juice, avena sativa (oat) kernel extract, bisabolol, boswellia serrata gum, butyrospermum parkii (shea butter) extract, cetyl alcohol, dextrin, dimethicone, dipropylene glycol, edetate disodium, glycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, magnesium ascorbyl phosphate, maltodextrin, methyl gluceth-20, methylparaben, petrolatum, phenoxyethanol, polysorbate 60, propylparaben, purified water, retinyl palmitate, sodium citrate, tocopheryl acetate, zingiber officinale (ginger) root extract

Questions?

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* Please review the disclaimer below.

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