After-bite

Aloe Vera Leaf, Matricaria Chamomilla Whole, Melaleuca Alternifolia Leaf And Rosemary


Ona Stick Usa Llc
Human Otc Drug
NDC 82610-002
After-bite also known as Aloe Vera Leaf, Matricaria Chamomilla Whole, Melaleuca Alternifolia Leaf And Rosemary is a human otc drug labeled by 'Ona Stick Usa Llc'. National Drug Code (NDC) number for After-bite is 82610-002. This drug is available in dosage form of Stick. The names of the active, medicinal ingredients in After-bite drug includes Aloe Vera Leaf - 1 [hp_X]/14g Matricaria Chamomilla Whole - 1 [hp_X]/14g Melaleuca Alternifolia Leaf - 1 [hp_X]/14g Rosemary - 1 [hp_X]/14g . The currest status of After-bite drug is Active.

Drug Information:

Drug NDC: 82610-002
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: After-bite
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: Aloe Vera Leaf, Matricaria Chamomilla Whole, Melaleuca Alternifolia Leaf And Rosemary
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Ona Stick Usa Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Stick
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:ALOE VERA LEAF - 1 [hp_X]/14g
MATRICARIA CHAMOMILLA WHOLE - 1 [hp_X]/14g
MELALEUCA ALTERNIFOLIA LEAF - 1 [hp_X]/14g
ROSEMARY - 1 [hp_X]/14g
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: UNAPPROVED HOMEOPATHIC
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: 15 Mar, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 22 Dec, 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.
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:ONA STICK USA LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UNII:ZY81Z83H0X
G0R4UBI2ZZ
G43C57162K
IJ67X351P9
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
82610-002-141 TUBE in 1 BLISTER PACK (82610-002-14) / 14 g in 1 TUBE15 Mar, 2022N/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:

Active ingredients purpose aloe barbadensis (aloe), 1x, 2.0% matricaria chamomila (chamomile), 2.0% melaleuca alternifolia (tea tree), 1x, 1.5% rosmarinus officinalis (rosemary), 1.5% for relief of itching and minor skin irritation due to insect bites.

Product Elements:

After-bite aloe vera leaf, matricaria chamomilla whole, melaleuca alternifolia leaf and rosemary aloe vera leaf aloe vera leaf matricaria chamomilla whole matricaria chamomilla whole melaleuca alternifolia leaf melaleuca alternifolia leaf rosemary rosemary argan oil yellow wax carnauba wax castor oil cocoa butter coconut oil isopropyl myristate jojoba oil lanolin mineral oil oleic acid ceresin stearyl alcohol

Indications and Usage:

Uses as a homeopathic medicine, these "uses" have not been evaluated by the food & drug administration. temporarily relieves itching and minor skin irritation due to insect bites.

Warnings:

Warnings for external use only. do not use if you are allergic to any of the active ingredients or inactive ingredients in this product. when using this product avoid contact with eyes and mouth do not use on wounds or irritated or damaged skin use only as directed do not apply tight wraps or bandages to treated areas do not apply heat to treated areas immediately before or after use stop use and ask a doctor if symptoms persist more than 3 days or worsen symptoms clear up and then reoccur within a few days keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Do Not Use:

Warnings for external use only. do not use if you are allergic to any of the active ingredients or inactive ingredients in this product. when using this product avoid contact with eyes and mouth do not use on wounds or irritated or damaged skin use only as directed do not apply tight wraps or bandages to treated areas do not apply heat to treated areas immediately before or after use stop use and ask a doctor if symptoms persist more than 3 days or worsen symptoms clear up and then reoccur within a few days keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

When Using:

When using this product avoid contact with eyes and mouth do not use on wounds or irritated or damaged skin use only as directed do not apply tight wraps or bandages to treated areas do not apply heat to treated areas immediately before or after use

Dosage and Administration:

Directions apply a thin layer to affected areas, massaging onto skin. repeat as needed.

Stop Use:

Stop use and ask a doctor if symptoms persist more than 3 days or worsen symptoms clear up and then reoccur within a few days

Package Label Principal Display Panel:

Principal display panel - 14 g tube blister pack chamomile • aloe • tea tree natural active ingredients after-bite oná stick ® insect bite balm homeopathic medicine | wellness at hand. goodbye itch! insect bite balm homeopathic medicine net wt 0.5 oz (14 g) principal display panel - 14 g tube blister pack

Further Questions:

Questions call 210.629.1343


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.