Gold Bond Baby Cornstarch Plus

Cornstarch And Kaolin And Zinc Oxide


Chattem, Inc.
Human Otc Drug
NDC 41167-0230
Gold Bond Baby Cornstarch Plus also known as Cornstarch And Kaolin And Zinc Oxide is a human otc drug labeled by 'Chattem, Inc.'. National Drug Code (NDC) number for Gold Bond Baby Cornstarch Plus is 41167-0230. This drug is available in dosage form of Powder. The names of the active, medicinal ingredients in Gold Bond Baby Cornstarch Plus drug includes Kaolin - .04 g/g Starch, Corn - .79 g/g Zinc Oxide - .15 g/g . The currest status of Gold Bond Baby Cornstarch Plus drug is Active.

Drug Information:

Drug NDC: 41167-0230
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: Gold Bond Baby Cornstarch 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: Cornstarch And Kaolin And Zinc Oxide
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Chattem, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Powder
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:KAOLIN - .04 g/g
STARCH, CORN - .79 g/g
ZINC OXIDE - .15 g/g
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 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: 29 Apr, 1996
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 12 Jun, 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: part347
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, 2023
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:Chattem, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1361201
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:0041167023044
UPC stands for Universal Product Code.
UNII:24H4NWX5CO
O8232NY3SJ
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
41167-0230-41 BOTTLE in 1 CARTON (41167-0230-4) / 113 g in 1 BOTTLE29 Apr, 1996N/ANo
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.

Purpose:

Purpose skin protectant

Product Elements:

Gold bond baby cornstarch plus cornstarch and kaolin and zinc oxide starch, corn starch, corn kaolin kaolin zinc oxide zinc oxide silicon dioxide

Indications and Usage:

Uses helps treat and prevent diaper rash protect chafed skin and helps relieve minor skin irritations due to diaper rash helps protect from wetness

Warnings:

Warnings for external use only. when using this product avoid contact with eyes do not use on broken skin keep powder away from child’s face to avoid inhalation, which can cause breathing problems stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days redness, irritation, swelling or pain persists or increases keep out of reach of children. if swallowed, get medical help or contact a poison control center immediately.

When Using:

When using this product avoid contact with eyes do not use on broken skin keep powder away from child’s face to avoid inhalation, which can cause breathing problems

Dosage and Administration:

Directions adults and children 2 years and older : apply freely up to 3 or 4 times daily. for best results, dry skin thoroughly before applying children under 2 years : change wet and soiled diapers promptly, cleanse the diaper area and allow to dry. apply powder liberally as often as necessary, with each diaper change, especially at bedtime, or anytime when exposure to wet diapers may be prolonged. apply powder close to the body away from child’s face. carefully shake the powder into the diaper or into the hand and apply to diaper area.

Stop Use:

Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days redness, irritation, swelling or pain persists or increases

Package Label Principal Display Panel:

Principal display panel cornstarch plus gold bond ® baby powder triple action relief helps prevent & treat diaper rash chafing minor skin irritations net wt 4 oz (113 g) principal display panel cornstarch plus gold bond® baby powder triple action relief helps prevent & treat diaper rash chafing minor skin irritations net wt 4 oz (113 g) principal display panel cornstarch plus gold bond® baby powder triple action relief helps prevent & treat diaper rash chafing minor skin irritations net wt 4 oz (113 g)


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.