NDC 63941-549 Diphenhydramine Hcl And Zinc Acetate

Extra Strength Itch Relief

NDC Product Code 63941-549

NDC 63941-549-88

Package Description: 88 mL in 1 CAN

NDC Product Information

Diphenhydramine Hcl And Zinc Acetate with NDC 63941-549 is a a human over the counter drug product labeled by Valu Merchandisers, Co. The generic name of Diphenhydramine Hcl And Zinc Acetate is extra strength itch relief. The product's dosage form is spray and is administered via topical form.

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.

Diphenhydramine Hcl And Zinc Acetate 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.

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

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: Valu Merchandisers, Co
Labeler Code: 63941
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: 12-11-2017 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.

Diphenhydramine Hcl And Zinc Acetate Product Label Images

Diphenhydramine Hcl 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 HCl 2.0%Zinc Acetate 0.1%

Purpose

  • External AnalgesicSkin protectant

Uses

  • For temporary relief of pain and itching associated with:minor burnssunburnsminor 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 temperature above 120ºF. Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.

Do Not Use

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

Ask A Doctor Before Use

  • On chicken poxon measles

Stop Use And Ask Doctor If

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

When Using This Product

  • Avoid contact with eyesuse only as directed

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 dailychildren under 2 years of age: ask a doctor

Other Information

Store between 20° to 25°C (68° to 77°F)

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.