NDC 11822-0219 Clear Anti-itch

Pramoxine Hcl, Zinc Acetate

NDC Product Code 11822-0219

NDC 11822-0219-6

Package Description: 177 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Clear Anti-itch with NDC 11822-0219 is a 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 RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1234546.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Clear Anti-itch 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)
  • CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • ROSEMARY OIL (UNII: 8LGU7VM393)
  • POLYSORBATE 40 (UNII: STI11B5A2X)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)

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: Rite Aid
Labeler Code: 11822
FDA Application Number: part347 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: 10-16-1997 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.

Clear Anti-itch Product Label Images

Clear Anti-itch 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

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

* Please review the disclaimer below.