NDC 70000-0023 Itch Relief

Diphenhydramine Hcl, Zinc Acetate

NDC Product Code 70000-0023

NDC 70000-0023-1

Package Description: 59 mL in 1 BOTTLE, SPRAY

Price per Unit: $0.04841 per ML

NDC Product Information

Itch Relief with NDC 70000-0023 is a a human over the counter drug product labeled by Cardinal Health, 110 Dba Leader. The generic name of Itch Relief is diphenhydramine hcl, zinc acetate. The product's dosage form is spray and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1053138.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

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.


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.

  • ALCOHOL (UNII: 3K9958V90M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POVIDONE (UNII: FZ989GH94E)
  • WATER (UNII: 059QF0KO0R)
  • TROMETHAMINE (UNII: 023C2WHX2V)

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: Cardinal Health, 110 Dba Leader
Labeler Code: 70000
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: 08-02-2011 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Itch Relief Product Label Images

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

Active Ingredients

Diphenhydramine HCl 2%Zinc Acetate 0.1%

Purpose

External analgesicSkin protectant

Uses

  • For the temporary relief of pain and itching associated with minor skin irritationsdries the oozing and weeping of poison: ivy, oak, sumac

Warnings

For external use only

Flammable

Keep away from fire of flame.

Do Not Use

  • On large areas of the bodywith any other product containing diphenhydramine, even one taken by mouth

Ask A Doctor Before Use

On chicken pox or measles

When Using This Product

Do not get into eyes

Stop Use And Ask A Doctor If

Condition worsens or symptoms last more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Do not use more than directedadults and children 2 years of age and older: apply to affected area not more than 3 to 4 times dailychildren under 2 years of age: ask a doctor

Other Information

• store at 20⁰ - 25⁰C (68⁰ - 77⁰F)

Inactive Ingredients

Alcohol, glycerin, povidone, purified water, tris (hydroxymethyl)aminomethane

Adverse Reactions

Dist. by CAH, Dublin, OH 430172019 Cardinal HealthThis product is not manufactured or distributed by Johnson & Johnson Consumer Products Company of the registered trademark Benadryl Extra Strength Spray.

* Please review the disclaimer below.