NDC 10356-120 Aquaphor Itch Relief

Hydrocortisone

NDC Product Code 10356-120

NDC 10356-120-04

Package Description: 28 g in 1 TUBE

NDC 10356-120-30

Package Description: .9 g in 1 PACKET

NDC 10356-120-52

Package Description: 1 TUBE in 1 CARTON > 28 g in 1 TUBE (10356-120-04)

NDC 10356-120-53

Package Description: 2 TUBE in 1 CARTON > 28 g in 1 TUBE (10356-120-04)

NDC Product Information

Aquaphor Itch Relief with NDC 10356-120 is a a human over the counter drug product labeled by Beiersdorf Inc. The generic name of Aquaphor Itch Relief is hydrocortisone. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Beiersdorf Inc

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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.

Aquaphor Itch Relief 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.

  • HYDROCORTISONE 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.

  • 3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • CERESIN (UNII: Q1LS2UJO3A)
  • LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • PETROLATUM (UNII: 4T6H12BN9U)

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.
  • 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: Beiersdorf Inc
Labeler Code: 10356
FDA Application Number: part348 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 11-01-2020 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: 12-31-2021 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.

Aquaphor Itch Relief Product Label Images

Aquaphor Itch Relief 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

Active IngredientHydrocortisone 1%

Otc - Purpose

PurposeAnti-Itch Ointment

Indications & Usage

Uses• for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:• eczema

• insect bites

• soaps

• poison ivy, oak, sumac

• seborrheic dermatitis

• psoriasis

• detergents

• cosmetics

• jewelry

Warnings

WarningsFor external use only

Otc - Do Not Use

Do not use
• for the treatment of diaper rash. Consult a doctor.

Otc - When Using

When using this product
• avoid contact with eyes

• do not exceed the recommended daily dosage unless directed by a doctor

Otc - Stop Use

Stop use and consult a doctor if
• condition worsens, 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

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.

Dosage & Administration

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: Do not use, consult a doctor.

Inactive Ingredient

Inactive ingredientsPetrolatum, Mineral Oil, Ceresin, Lanolin Alcohol,

Panthenol, Glycerin, Bisabolol, Menthoxypropanediol

Otc - Questions

Questions or comments?
1-800-227-4703

* Please review the disclaimer below.