Moxie

Ethyl Alcohol


Apollo Health And Beauty Care
Human Otc Drug
NDC 63148-660
Moxie also known as Ethyl Alcohol is a human otc drug labeled by 'Apollo Health And Beauty Care'. National Drug Code (NDC) number for Moxie is 63148-660. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Moxie drug includes Alcohol - 700 mg/mL . The currest status of Moxie drug is Active.

Drug Information:

Drug NDC: 63148-660
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: Moxie
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: Ethyl Alcohol
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Apollo Health And Beauty Care
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Gel
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:ALCOHOL - 700 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: 02 Mar, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 15 Jan, 2025
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: part333E
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:Apollo Health and Beauty Care
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:581662
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:0670456968966
0670456968973
UPC stands for Universal Product Code.
UNII:3K9958V90M
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
63148-660-24710 mL in 1 BOTTLE, PLASTIC (63148-660-24)02 Mar, 2021N/ANo
63148-660-501470 mL in 1 BOTTLE, PLASTIC (63148-660-50)02 Mar, 2021N/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 antiseptic

Product Elements:

Moxie ethyl alcohol alcohol alcohol water polyethylene glycol 300 isopropyl alcohol glycerin isopropyl myristate aloe vera leaf .alpha.-tocopherol acetate, dl- acrylates/vinyl isodecanoate crosspolymer (10000 mpa.s neutralized at 0.5%) ethylene brassylate

Indications and Usage:

Uses for personal hand hygiene to help the spread of bacteria. can be used in place of hand washing if soap and water are not available.

Warnings:

Warnings for external use only flammable keep away from source of heat or fire. when using this product avoid contact with eyes. if contact occurs, rinse eyes thoroughly with water. do not inhale. do not use on children less than 2 months of age on open skin wounds on broken or damaged skin stop use and ask a doctor if irritation or redness develops and lasts. keep out of reach of children in case of accidental ingestion, get medical help or contact a poison control centre immediately

Do Not Use:

Warnings for external use only flammable keep away from source of heat or fire. when using this product avoid contact with eyes. if contact occurs, rinse eyes thoroughly with water. do not inhale. do not use on children less than 2 months of age on open skin wounds on broken or damaged skin stop use and ask a doctor if irritation or redness develops and lasts. keep out of reach of children in case of accidental ingestion, get medical help or contact a poison control centre immediately

When Using:

When using this product avoid contact with eyes. if contact occurs, rinse eyes thoroughly with water. do not inhale.

Dosage and Administration:

Directions for occasional and personal use rub thoroughly into hands for at least 30 seconds. allow to dry children under 6 years should be supervised when using this product

Stop Use:

Stop use and ask a doctor if irritation or redness develops and lasts.

Package Label Principal Display Panel:

24 oz sanitizer 24 oz sanitizer

50 oz sanitizer 50 oz sanitizer


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.