NDC 62917-819 Theraplex Aim Anti-itch Moisturizing Cream

Hydrocortisone

NDC Product Code 62917-819

NDC 62917-819-03

Package Description: 1 JAR in 1 CARTON > 85 g in 1 JAR

NDC Product Information

Theraplex Aim Anti-itch Moisturizing Cream with NDC 62917-819 is a a human over the counter drug product labeled by The Theraplex Company, Llc. The generic name of Theraplex Aim Anti-itch Moisturizing Cream is hydrocortisone. The product's dosage form is cream and is administered via topical form.

Labeler Name: The Theraplex Company, Llc

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 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.

Theraplex Aim Anti-itch Moisturizing Cream 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.

  • PETROLATUM (UNII: 4T6H12BN9U)
  • CYCLOMETHICONE (UNII: NMQ347994Z)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • FERULIC ACID (UNII: AVM951ZWST)
  • OATMEAL (UNII: 8PI54V663Y)

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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: The Theraplex Company, Llc
Labeler Code: 62917
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: 08-15-2019 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: 12-31-2020 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.

Theraplex Aim Anti-itch Moisturizing Cream Product Label Images

Theraplex Aim Anti-itch Moisturizing Cream 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, inflammation, and rashes due to:•eczema •soaps •detergents •cosmetics •seborrheic dermatitis •psoriasis. •Other uses of this product should only be 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.• Stop use and ask a doctor if condition worsens, symptoms persist more than 7 days, or clear up and occur again within a few days. 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.

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, ask a doctor.

Inactive Ingredients

Petrolatum (special fraction), cyclomethicone, coconut oil, microcrystalline wax, ferulic acid, colloidal oatmeal

Other Information

• Store at 20° to 25°C (68° to 77°F)

Questions?

• Toll-free number 888-437-2753 • For more information on Eczema and Theraplex, visit us on our website at www.theraplex.com

* Please review the disclaimer below.