NDC 63868-877 Poison Ivy Wash

Pramoxine Hcl

NDC Product Code 63868-877

NDC Product Information

Poison Ivy Wash with NDC 63868-877 is a a human over the counter drug product labeled by Chain Drug Market Association. The generic name of Poison Ivy Wash is pramoxine hcl. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Chain Drug Market Association

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.

Poison Ivy Wash 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.

  • PRAMOXINE HYDROCHLORIDE 10 mg/mL

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.

  • GLYCOL DISTEARATE (UNII: 13W7MDN21W)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
  • HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • NONOXYNOL-9 (UNII: 48Q180SH9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • WATER (UNII: 059QF0KO0R)

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: Chain Drug Market Association
Labeler Code: 63868
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: 04-24-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Poison Ivy Wash Product Label Images

Poison Ivy Wash 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

Otc - Active Ingredient

Pramoxine HCl 1%

Otc - Purpose

External Analgesic

Indications & Usage

For temporary relief of pain and itching associated with poison ivy, poison oak, and poison sumac.

Warnings

For external use only.When using this product:Avoid Contact with eyes.Do not leave on skin longer than 3 minutesRinse thoroughly after application

Otc - When Using

When using this product avoid contact with the eyes. Do not leave on skin longer than 3 minutes. Rinse thoroughly after application.

Otc - Ask Doctor

Stop use and ask a doctor if condition worses, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Dosage & Administration

Adults and children 2 years of age and older: wet the affected area, apply product to affected skin and surrounding area. work foam into lather and rub for up to 3 minutes if needed. do not leave on skin for longer than 3 minutes. Thoroughly rinse product form all areas. Apply to affected are not more than 3 to 4 times daily.

Inactive Ingredient

Waterammonium lauryl sulfaredistearyl phtalic acid amideglycol distereatecocamide MIPAPropylene glycolDiazolidyn UreaMethylparaben

Propylparaben
GlycerinJojoba estersdisodium edtasodium hydroxidenonoxynol-9

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

* Please review the disclaimer below.

Previous Code
63868-876
Next Code
63868-898