NDC 72663-155 Welly Itch Fix

Hydrocortisone Anti Itch Cream

NDC Product Code 72663-155

NDC Product Information

Welly Itch Fix with NDC 72663-155 is a a human over the counter drug product labeled by Welly Health Pbc. The generic name of Welly Itch Fix is hydrocortisone anti itch cream. The product's dosage form is cream and is administered via topical form.

Labeler Name: Welly Health Pbc

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.


Welly Itch Fix 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 10 mg/g

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)
  • ALUMINUM SULFATE (UNII: 34S289N54E)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • CALCIUM ACETATE (UNII: Y882YXF34X)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • ICODEXTRIN (UNII: 2NX48Z0A9G)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • 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: Welly Health Pbc
Labeler Code: 72663
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: 02-22-2019 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.

Welly Itch Fix Product Label Images

Welly Itch Fix 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

Other

Drug Facts

Active Ingredient

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses

  • For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
  • Eczema
  • Insect bites
  • Poison ivy
  • Poison oak
  • Poison sumac
  • Soaps
  • Detergents
  • Cosmetics
  • Jewelry
  • Seborrheic dermatitis
  • Psoriasis
  • External feminine, genital and anal itching.
  • 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.
  • For external genital itching if you have a vaginal discharge, consult a doctor.

When Using This Product

  • Avoid contact with eyes
  • Do not begin the use of any other hydrocortisone product unless you have consulted a doctor.
  • For external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use, consult a doctor.
  • Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop Use And Ask A Doctor If

  • If condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.

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.

Adults And Children 2 Years And Older

  • Apply to affected area not more than 3 to 4 times daily.

Children Under 2 Years Of Age

  • Do not use. Consult a doctor.

For External Anal Itching:

  • Adults: when practical cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • Children under 12 years of age with external anal itching: consult a doctor.

Other Information

Store at controlled room temperature 68° - 77ºF (20°-25°C).

Inactive Ingredients

Aloe barbadensis leaf extract, Benzyl alcohol, Ceteareth-20, Cetearyl alcohol, Cetyl palmitate, Glycerin, Isopropyl myristate, Isostearyl neopentanoate, Methylparaben, PEG-40 stearate, Propylene glycol, Purified water

* Please review the disclaimer below.

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