NDC 36800-739 Effective Itch Relief

Product Information

Product Code36800-739
Proprietary Name What 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.
Effective Itch Relief
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Topco
Labeler Code36800
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
01-22-2013
Listing Expiration Date 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.
12-31-2019
Exclude Flag 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".
I
NDC Code Structure

Usage Information


Product Packages

NDC 36800-739-03

Package Description: 85 g in 1 CAN

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Effective Itch Relief is product labeled by Topco. The product's dosage form is and is administered via form.


What are Effective Itch Relief Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

  • DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40)
  • DIPHENHYDRAMINE (UNII: 8GTS82S83M) (Active Moiety)
  • ZINC ACETATE (UNII: FM5526K07A)
  • ZINC CATION (UNII: 13S1S8SF37) (Active Moiety)


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:


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)


* Please review the disclaimer below.

Effective Itch Relief Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredients



Diphenhydramine HCl 2.0%

Zinc Acetate 0.10%


Purpose



Topical analgesic

Skin protectant


Uses



Temporarily relieves pain and itching associated with:

  • insect bites
  • minor burns
  • sunburn
  • minor cuts
  • scrapes
  • minor skin irritations
  • rashes due to poison ivy, oak and sumac
  • dries the oozing and weeping of poison ivy, oak and sumac

Warnings



For external use only.

Flammable - Do not use while smoking or near heat or flame ​​​​


Do Not Use



  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth
  • on chicken pox

Stop Use And Ask A Doctor If



  • condition worsens
  • symptoms last more than 7 days
  • symptoms clear up and occur again in a few days

Keep Out Of Reach Of Children.



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


Directions



  • shake well
  • 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
  • to apply to face, spray into palm of hand and gently apply

Inactive Ingredients



Alcohol Denat.
Glycerin
PVP
Tromethamine
Water


* Please review the disclaimer below.