NDC 70000-0397 Calamine Clear

Pramoxine Hydrochloride And Zinc Acetate Lotion

NDC Product Code 70000-0397

NDC Code: 70000-0397

Proprietary Name: Calamine Clear Additional informationCallout TooltipWhat 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.

Non-Proprietary Name: Pramoxine Hydrochloride And Zinc Acetate Lotion Additional informationCallout TooltipWhat 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.


Code Structure
  • 70000 - Cardinal Health
    • 70000-0397 - Calamine Clear

NDC 70000-0397-1

Package Description: 177 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Calamine Clear with NDC 70000-0397 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Calamine Clear is pramoxine hydrochloride and zinc acetate 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 Additional informationCallout TooltipWhat 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.


Calamine Clear Active Ingredient(s)

Additional informationCallout TooltipWhat 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
  • ZINC ACETATE 1 mg/mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • ALCOHOL (UNII: 3K9958V90M)
  • CAMPHOR (NATURAL) (UNII: N20HL7Q941)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 01-15-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Calamine Clear Product Label Images

Calamine Clear 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%Zinc Acetate 0.1%

Otc - Purpose

External Analgesic & Skin Protectant

Indications & Usage

Temporarily Relieves Pain and Itching Associated with:rashes due to poison ivy, poison oak, or poison sumac

insect bites

minor skin irritation

minor cuts

dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

For external use only. Use only as directed.
Acoid contact with eyes and mucous membranes
Ask a doctor before using on children under 2 years of age.

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)

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 fo the affected area using cotton or soft cloth, not more than 3 to 4 times dialy as needed for comfort.

Inactive Ingredient

SD Alcohol 38B 2.5%CamphorDiazolidinyl UseaFragrancesGlycerinHydroxypropyl MethylcelluloseMethylparabenPolysorbate 80Propylene GlycolPropylparabenPurified Water

* Please review the disclaimer below.

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