Calamine Plus

Ferric Oxide Red, Pramoxine Hydrochloride, Zinc Oxide

Wal-mart Stores, Inc.
Human Otc Drug
NDC 49035-030

Calamine Plus also known as Ferric Oxide Red, Pramoxine Hydrochloride, Zinc Oxide is a human otc drug labeled by 'Wal-mart Stores, Inc.'. National Drug Code (NDC) number for Calamine Plus is 49035-030. This drug is available in dosage form of Aerosol, Spray. The names of the active, medicinal ingredients in Calamine Plus drug includes Ferric Oxide Red - .345 mg/mL Pramoxine Hydrochloride - 2.72 mg/mL Zinc Oxide - 24.16 mg/mL . The currest status of Calamine Plus drug is Active.

Drug Information:

Drug NDC:	49035-030
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Calamine Plus
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Ferric Oxide Red, Pramoxine Hydrochloride, Zinc Oxide
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Wal-mart Stores, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Aerosol, Spray
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	FERRIC OXIDE RED - .345 mg/mL PRAMOXINE HYDROCHLORIDE - 2.72 mg/mL ZINC OXIDE - 24.16 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	OTC MONOGRAPH NOT FINAL
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	03 Mar, 2013
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	07 May, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	part348
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.
Listing Expiration Date:	31 Dec, 2024
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Wal-Mart Stores, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1544717
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0681131052894
UPC stands for Universal Product Code.
UNII:	1K09F3G675 88AYB867L5 SOI2LOH54Z
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
49035-030-01	177 mL in 1 CANISTER (49035-030-01)	03 Mar, 2013	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Calamine Plus

Ferric Oxide Red, Pramoxine Hydrochloride, Zinc Oxide

Aerosol, Spray
Wal-Mart Stores, Inc.
NDC: 49035-030

Purpose:

Purpose purpose skin protectant external analgesic

Product Elements:

Calamine plus ferric oxide red, pramoxine hydrochloride, zinc oxide benzyl alcohol camphor (synthetic) hydrated silica isobutane oleyl alcohol sorbitan trioleate ferric oxide red ferric oxide red pramoxine hydrochloride pramoxine zinc oxide zinc oxide

Indications and Usage:

Uses uses temporarily relieves pain and itching associated with: insect bites rashes minor skin irritations minor cuts dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings:

Warnings warnings for external use only. use only as directed. intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

When Using:

When using this product when using this product do not get into eyes ask a doctor before using on children under 2 years of age

Dosage and Administration:

Directions directions shake well before using adults and children 2 years of age and older cleanse the skin with soap and water let dry before use apply as needed to the affected area, not more than 3 to 4 times a day

Stop Use:

Stop use and ask a doctor if stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again in a few days

Package Label Principal Display Panel:

Principal display panel equate no-rub calamine plus spray calamine 8%, pramoxine hcl 1% external analgesic, skin protectant relieves pain & itching from: poison ivy, oak and sumac sprays on pink net wt 4.1 oz (116 g) calamine plus spray

Further Questions:

Questions? questions ? call 1-866-964-0939

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.