NDC 41520-090 Diphenhydramine Hci And Zinc Acetate

Itch Relief Continuous Spray

NDC Product Code 41520-090

NDC Code: 41520-090

Proprietary Name: Diphenhydramine Hci And Zinc Acetate Additional informationCallout TooltipWhat 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.

Non-Proprietary Name: Itch Relief Continuous Spray Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 41520 - Foodhold Usa
    • 41520-090 - Diphenhydramine Hci And Zinc Acetate

NDC 41520-090-76

Package Description: 76 g in 1 CANISTER

NDC Product Information

Diphenhydramine Hci And Zinc Acetate with NDC 41520-090 is a a human over the counter drug product labeled by Foodhold Usa. The generic name of Diphenhydramine Hci And Zinc Acetate is itch relief continuous spray. The product's dosage form is aerosol, spray and is administered via topical form.

Labeler Name: Foodhold Usa

Dosage Form: Aerosol, Spray - An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous solvents.

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.


Diphenhydramine Hci And Zinc Acetate 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.

  • BROMODIPHENHYDRAMINE HYDROCHLORIDE 1.52 g/76g
  • ZINC ACETATE .076 g/76g

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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • TROMETHAMINE (UNII: 023C2WHX2V)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

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: Foodhold Usa
Labeler Code: 41520
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: 03-04-2019 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.

Diphenhydramine Hci And Zinc Acetate Product Label Images

Diphenhydramine Hci And Zinc Acetate 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 HCI 2.0%Zinc Acetate 0.1%

Purpose

External AnalgesicSkin Protectant

Uses

  • For the temporary relief of pain and itching associated with:minor burns sunburnminor cutsscrapesinsect bitesminor skin irritationsrashes due to poison ivy, poison oak and poison sumacdries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

For external use only.

Flammable:

Keep away from fire or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

Do Not Use

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

Ask A Doctor Before Use

  • On chicken poxon measles

When Using This Product

  • Avoid contact with eyes

Stop Use And Ask Doctor If

  • Condition worsenssymptoms last more than 7 days or clear up and occur again within a few days

Keep Out Of The Reach Of Children.

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

Directions

  • Do not use more often 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 between 20º to 25ºC (68º to 77ºF)

Inactive Ingredients

Aloe barbadensis leaf juice, glycerin, purified water, SD alcohol 40-B, tromethamine

Questions?

Call 1-866-964-0939

* Please review the disclaimer below.

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