NDC 11822-0219 Clear Anti-itch
Pramoxine Hcl, Zinc Acetate Lotion Topical

Product Information

What is NDC 11822-0219?

The NDC code 11822-0219 is assigned by the FDA to the product Clear Anti-itch which is a human over the counter drug product labeled by Rite Aid. The generic name of Clear Anti-itch is pramoxine hcl, zinc acetate. The product's dosage form is lotion and is administered via topical form. The product is distributed in a single package with assigned NDC code 11822-0219-6 177 ml in 1 bottle, plastic . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code11822-0219
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.
Clear Anti-itch
Non-Proprietary Name What 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.
Pramoxine Hcl, Zinc Acetate
Product Type 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.
Human Otc Drug
Dosage FormLotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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.
Rite Aid
Labeler Code11822
FDA Application Number 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.
part347
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
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.
10-16-1997
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.
12-31-2023
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".
N
NDC Code Structure

What are the uses for Clear Anti-itch?


Product Packages

NDC Code 11822-0219-6

Package Description: 177 mL in 1 BOTTLE, PLASTIC

Product Details

What are Clear Anti-itch Active Ingredients?

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.

Clear Anti-itch Active Ingredients UNII Codes

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 indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1234546 - pramoxine HCl 1 % / zinc acetate 0.1 % Topical Lotion
  • RxCUI: 1234546 - pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical Lotion

Clear Anti-itch Inactive Ingredients UNII Codes

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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Clear Anti-itch Product Label

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.

Product Label Table of Contents



Active Ingredients



Pramoxine HCl 1%
Zinc acetate 0.1%


Purpose



External analgesic
Skin protectant


Uses



•for the temporary relief of pain and itching associated with minor skin
 irritations and rashes due to poison ivy, poison oak, or poison sumac
•dries the oozing and weeping of poison: •ivy •oak •sumac


Warnings



For external use only


When Using This Product



•do not get into eyes


Stop Use And Ask A Doctor If



•condition worsens •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



•shake well  •before applying wash affected area of skin
adults and children 2 years of age and older - apply to affected area no more than 3 to 4 times daily
children under 2 years - ask a doctor


Other Information



store at room temperature (59⁰ - 77⁰ F)


Inactive Ingredients



alcohol, camphor, citric acid, diazolidinyl urea, fragrance, glycerin, hypromellose, methylparaben, oil of lavender, oil of rosemary, polysorbate 40, propylene glycol, propylparaben, purified water, sodium citrate


Adverse Reaction



*This product is not manufactured or distributed by Pfizer Consumer HealthCare, distributor of Caladryl Clear Lotion.

DISTRIBUTED BY: RITE AID
30 HUNTER LANE
CAMP HILL, PA17011


Principal Display Panel




* Please review the disclaimer below.