NDC 70000-0400 Leader Calamine Plus

Zinc Oxide Lotion

NDC Product Code 70000-0400

NDC Product Information

Leader Calamine Plus with NDC 70000-0400 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Leader Calamine Plus is zinc oxide lotion. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Cardinal Health

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.


Leader Calamine Plus 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.

  • ZINC OXIDE 80 mg/mL
  • 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.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ALCOHOL (UNII: 3K9958V90M)
  • CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • 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: Cardinal Health
Labeler Code: 70000
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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 02-15-2019 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.

Leader Calamine Plus Product Label Images

Leader Calamine Plus 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

Warnings

  • For external use onlyAvoid contact with eyes and mucous membranesAsk a doctor before using on children under 2 years of age

Otc - Active Ingredient

Calamine 8%Pramoxine HCl 1%

Otc - Purpose

  • Skin ProtectantExternal Analgesic

Dosage & Administration

Adults and children 2 years of age and older: Shake well before using. CLeanse the skin with soap and water and let dry before each use. Apply lotion to the affected area using cotton of soft cloth, not more than 3 to 4 times daily as needed for comfort.Children under 2 years of age: Consult a doctor before use.

Inactive Ingredient

SH Alcohol 38B 2.5%CamphorDiazolidinyl UreaFragrancesGlycerinHydroxypropyl MethylcelluloseMethylparabenPolysorbate 80Propylene GlycolPropylparabarenPurified water

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222)

Indications & Usage

  • Uses:
  • Temporarily relieves pain and itching associated with:
  • Rashes due to poison ivy, poison oak, or poison sumacinsect bitesminor skin irritationminor cuts​dries the oozing and weeping of poison ivy, poison oak and poison sumac

* Please review the disclaimer below.

Previous Code
70000-0399
Next Code
70000-0401