Traveling Farmacy

Menthol


Natures Formulae Health Products Ltd.
Human Otc Drug
NDC 69204-021
Traveling Farmacy also known as Menthol is a human otc drug labeled by 'Natures Formulae Health Products Ltd.'. National Drug Code (NDC) number for Traveling Farmacy is 69204-021. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Traveling Farmacy drug includes . The currest status of Traveling Farmacy drug is Active.

Drug Information:

Drug NDC: 69204-021
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: Traveling Farmacy
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: Menthol
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Natures Formulae Health Products Ltd.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Kit
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:
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: 01 Nov, 2017
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 16 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: part341,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, 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:Natures Formulae Health Products Ltd.
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:
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
69204-021-018 BOTTLE, DROPPER in 1 BOTTLE, DROPPER (69204-021-01) / 1 KIT in 1 BOTTLE, DROPPER * 3 mL in 1 BOTTLE, DROPPER * 3 mL in 1 BOTTLE, DROPPER * 3 mL in 1 BOTTLE, DROPPER * 3 mL in 1 BOTTLE, DROPPER * 3 mL in 1 BOTTLE, DROPPER * 3 mL in 1 BOTTLE, DROPPER * 3 mL in 1 BOTTLE, DROPPER * 3 mL in 1 BOTTLE, DROPPER01 Nov, 2017N/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:

Fortify purpose: antitussive (cough suppressant)

Pain release purpose: topical analgesic

Product Elements:

Traveling farmacy menthol pain release menthol sweet marjoram oil eucalyptus oil cajuput oil grape seed oil chamaemelum nobile flower oil lavender oil rosemary oil peppermint oil menthol menthol brainstorm n/a orange oil pelargonium graveolens flower oil cedrus atlantica wood oil clary sage oil jojoba oil myrtle leaf oil lemon oil clove oil energy n/a grape seed oil peppermint oil peppermint rosemary oil bergamot oil lemon oil basil oil fortify menthol cinnamon oil pelargonium graveolens flower oil rosemary oil eucalyptus oil pine needle oil (pinus sylvestris) tea tree oil grape seed oil peppermint oil peppermint menthol menthol peppermint halo n/a peppermint oil peppermint rosemary oil vetiver oil lavender oil eucalyptus oil cajuput oil gutzy n/a grape seed oil chamomile flower oil peppermint oil peppermint black pepper oil myrrh oil fennel oil stress release n/a myrtle leaf oil grape seed oil pelargonium graveolens flower oil orange oil lavender oil chamomile flower oil vetiver oil clary sage oil sleep well n/a citrus aurantium fruit oil bitter orange oil chamomile flower oil vetiver oil sweet marjoram oil jasminum officinale whole valerian oil citrus reticulata fruit oil lavender oil matricaria chamomilla flowering top oil

Indications and Usage:

Fortify uses: temporarily calms cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants. relieves the impulse to cough to help you rest.

Pain release for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings:

Fortify for external use only . do not take by mouth or place in nostrils. flammable : keep away from fire or flame. do not use • if epileptic • with high blood pressure. ask a doctor before use if you have • persistent or chronic cough such as occurs with smoking, asthma, or emphysema • cough accompanied by excessive phlegm (mucus). when using this product , do not • heat • microwave • use near an open flame • add to hot water or any container where heating water. may cause splattering and result in burns. stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. a persistent cough may be a sign of a serious condition. if pregnant or breast-feeding, do not use this product. fortify keep out of reach of children . if product is swallowed, get medical help or contact a poison control center right away.

Pain release for external use only. flammable . keep away from fire or flame. do not use • on wounds or damaged skin • if epileptic • with high blood pressure. when using this product • avoid contact with the eyes • do not bandage tightly. stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. if pregnant or breast-feeding , do not use this product. pain release keep out of reach of children. if product is swallowed, get medical help or contact a poison control center right away.

Peppermint halo warnings: - keep out of reach of children. - for external use only. if swallowed, seek urgent care/call poison control. - if skin sensitization occurs, rinse with vegetable oil. - avoid eyes & mucous membranes; if contact occurs, rinse with vegetable oil. - do not use if pregnant/breastfeeding, with high/low blood pressure, or if epileptic. - if allergic reaction occurs, stop use & consult a doctor.

Gutzy - keep out of reach of children. - for external use only. if swallowed, seek urgent care/call poison control. - avoid eyes & mucous membranes; if contact occurs, rinse with vegetable oil. - do not use if pregnant/breastfeeding or if epileptic. - if allergic reaction occurs, stop use & consult a doctor.

Stress release - keep out of reach of children. - for external use only. if swallowed, seek urgent care/call poison control. - avoid eyes & mucous membranes; if contact occurs, rinse with vegetable oil. - do not use if pregnant/breastfeeding. - if allergic reaction occurs, stop use & consult a doctor. – phototoxic; do not sun tan/use tanning beds for 3-4 days after use.

Brainstorm - keep out of reach of children. - for external use only. if swallowed, seek urgent care/call poison control. - avoid eyes & mucous membranes; if contact occurs, rinse with vegetable oil. - do not use if pregnant/breastfeeding. - if allergic reaction occurs, stop use & consult a doctor. - phototoxic; do not sun tan/use tanning beds for 3-4 days after use.

Energy - keep out of reach of children. - for external use only. if swallowed, seek urgent care/call poison control. - avoid eyes & mucous membranes; if contact occurs, rinse with vegetable oil. - do not use if pregnant/breastfeeding, on inflamed skin/dermatitis, or if epileptic. - if allergic reaction occurs, stop use & consult a doctor. - contains phototoxic lemon & bergamot essential oils; do not sun tan/use tanning beds for 3-4 days after use.

Sleep well - keep out of reach of children. - for external use only. if swallowed, seek urgent care/call poison control. - avoid eyes & mucous membranes; if contact occurs, rinse with vegetable oil. - do not use if pregnant/breastfeeding. - if allergic reaction occurs, stop use & call a doctor. - phototoxic; do not sun tan/use tanning beds for 3-4 days after use.

Dosage and Administration:

Fortify adults and children 12 years and older: rub on the throat and chest in a thick layer. cover with a warm, dry cloth if desired. clothing should be loose about throat and chest to help vapors reach the nose and mouth. use up to three times daily or as directed by a doctor. children under 12 years of age: ask a doctor. apply to the following areas, as directed: a - throat; b – chest. important: read all product information before using. keep this package for full information.

Pain release adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily. not recommended for children under 12 years of age. apply to muscles & joints experiencing minor aches & pains, as directed: a - shoulders b - neck c - back important: read all product information before using. keep this package for full information.

Description:

Traveling farmacy oil blend convenience kit 1 antitussive (cough suppressant) oil blend rub, 0.1 fl. oz. (3 ml); 1 topical analgesic oil blend, 0.1 fl. oz. (3 ml); 6 oil blends, 0.1 fl. oz. (3 ml) ea

Traveling farmacy - company information and other information distributed by: saje natural wellness 500 - 88 east pender st. vancouver, bc canada v6a 3x3; saje.com; @sajewellness; made by our friends in canada. for questions or to report adverse events associated with use, call 1-877-275-7253 do not use if security seal around bottles is broken or missing

Package Label Principal Display Panel:

Traveling farmacy oil blend convenience kit -outer label box label


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.