NDC 41520-184 Calamine Plus Pramoxine Hcl

Calamine Plus Spray

NDC Product Code 41520-184

NDC Product Information

Calamine Plus Pramoxine Hcl with NDC 41520-184 is a a human over the counter drug product labeled by Foodhold Usa. The generic name of Calamine Plus Pramoxine Hcl is calamine plus spray. The product's dosage form is aerosol, spray and is administered via topical form.

Labeler Name: Foodhold Usa

Dosage Form: Aerosol, Spray - An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous solvents.

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.

Calamine Plus Pramoxine Hcl 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 24.16 mg/116g
  • PRAMOXINE HYDROCHLORIDE 2.72 mg/116g
  • FERRIC OXIDE RED .345 mg/116g

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.

  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • OLEYL ALCOHOL (UNII: 172F2WN8DV)
  • ALCOHOL (UNII: 3K9958V90M)
  • SORBITAN TRIOLEATE (UNII: QE6F49RPJ1)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • ISOBUTANE (UNII: BXR49TP611)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)

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: Foodhold Usa
Labeler Code: 41520
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: 02-01-2019 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: 12-31-2019 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.

Calamine Plus Pramoxine Hcl Product Label Images

Calamine Plus Pramoxine Hcl 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 Ingredient

Calamine 8%

Pramoxine HCl 1%

Purpose

Skin protectant

External analgesic

Uses

  • Temporarily relieves pain and itching associated with:insect bitesrashesminor skin irritationsminor cutsdries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

For external use only.

Flammable:

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF. Intentional misuse by delibrately concentrating and inhaling contents can be harmful or fatal.

When Using This Product

  • Do not get into eyesask a doctor before using on children under 2 years of age

Stop Use And Ask A Doctor If

  • Conditions worsenssymptoms last more than 7 days or clear up and occur again in 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 usingadults and children 2 years of age and older: apply as needed to the affected area, not more than 3 or 4 times dailycleanse the skin with soap and waterlet dry before usechildren under 2 years of age: consult a doctor

Other Information

Store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

Benzyl alcohol, camphor, disteardimonium hectorite, fragrance, hydrated silica, isobutane, oleyl alcohol, SD alcohol 40-B, sorbitan trioleate

Questions?

Call 1-866-964-0939

* Please review the disclaimer below.

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