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| Product NDC Code | 70983-020 | ||||
|---|---|---|---|---|---|
| Drug Name | Traveling farmacy |
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| Type | Brand | ||||
| Route | TOPICAL | ||||
| Dosage Form | KIT | ||||
| Application Number | M012 | ||||
| Labeler Name | Saje Natural Business Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Fortify Active ingredients: Menthol 2.7% ; Purpose: Antitussive (cough suppresant)
Pain Release Active ingredient: Menthol 1.98% Purpose: Topical analgesic
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.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
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Fortify inactive ingredients: cinnamon oil, eucalyptus oil, melaleuca alternifolia (tea tree) leaf oil, pelargonium graveolens oil, peppermint oil, pine needle oil, rosmarinus officinalis (rosemary) leaf oil, and vitis vinifera (grape) seed oil.
Pain Release anthemis nobilis flower oil, eucalyptus oil, lavender oil, melaleuca leucadendron cajaput oil, origanum majorana leaf oil, peppermint oil, rosmarinus officinalis (rosemary) leaf oil, and vitis vinifera (grape) seed oil.
Peppermint Halo Ingredients: mentha piperita (peppermint) oil, eucalyptus globulus leaf oil, melaleuca leucadendron cajaput oil, rosmarinus officinalis (rosemary) leaf oil, lavandula angustifolia (lavender) oil, and vetiveria zizanoides root oil.
Gutzy Ingredients : vitis vinifera (grape) seed oil, foeniculum vulgare (fennel) oil, mentha piperita (peppermint) oil, anthemis nobilis flower oil, piper nigrum (pepper) seed oil, and commiphora myrrha oil.
Stress Release Ingredients: vitis vinifera (grape) seed oil, lavandula angustifolia (lavender) oil, citrus aurantium dulcis (orange) peel oil, anthemis nobilis flower oil, vetiveria zizanoides root oil, pelargonium graveolens oil, salvia sclarea (clary) oil, and myrtus communis oil.
Brainstorm Ingredients: simmondsia chinensis (jojoba) seed oil, myrtus communis oil, citrus limon (lemon) peel oil, citrus aurantium dulcis (orange) peel oil, pelargonium graveolens oil, cedrus atlantica wood oil, salvia sclarea (clary) oil, eugenia caryophyllus (clove) flower oil.
Energy Ingredients : vitis vinifera (grape) seed oil, citrus limon (lemon) peel oil, rosmarinus officinalis (rosemary) leaf oil, mentha piperita (peppermint) oil, citrus aurantium bergamia (bergamot) fruit oil and ocimum basilicum (basil) oil.
Sleep Well ingredients : lavandula angustifolia (lavender) oil, citrus aurantium dulcis (orange) peel oil, citrus reticulata (tangerine) peel oil, anthemis nobilis flower oil, chamomilla recutita (matricaria) flower oil, vetiveria zizanioides root oil, origanum majorana leaf oil, valeriana officinalis root oil, jasminum officinale (jasmine) oil and citrus aurantium amara (bitter orange) flower oil.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Purpose
Information about the drug product’s indications for use.Fortify Purpose: Antitussive (Cough Suppressant)
Pain Release Purpose: Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Traveling Farmacy Menthol Fortify Menthol MENTHOL MENTHOL CINNAMON OIL PELARGONIUM GRAVEOLENS FLOWER OIL ROSEMARY OIL GRAPE SEED OIL EUCALYPTUS OIL PINE NEEDLE OIL (PINUS SYLVESTRIS) TEA TREE OIL PEPPERMINT OIL PEPPERMINT Pain Release menthol PEPPERMINT OIL ROSEMARY OIL SWEET MARJORAM OIL EUCALYPTUS OIL CAJUPUT OIL GRAPE SEED OIL LAVENDER OIL MENTHOL MENTHOL CHAMAEMELUM NOBILE FLOWER OIL Peppermint halo N/A CAJUPUT OIL PEPPERMINT OIL PEPPERMINT ROSEMARY OIL VETIVER OIL LAVENDER OIL EUCALYPTUS OIL Gutzy N/A GRAPE SEED OIL CHAMOMILE FLOWER OIL PEPPERMINT OIL PEPPERMINT BLACK PEPPER OIL MYRRH OIL FENNEL OIL Stress Release N/A CHAMOMILE FLOWER OIL VETIVER OIL CLARY SAGE OIL MYRTLE LEAF OIL GRAPE SEED OIL PELARGONIUM GRAVEOLENS FLOWER OIL ORANGE OIL LAVENDER OIL Sleep well N/A CITRUS RETICULATA FRUIT OIL LAVENDER OIL CITRUS AURANTIUM FRUIT OIL SWEET MARJORAM OIL JASMINUM OFFICINALE WHOLE VALERIAN OIL MATRICARIA CHAMOMILLA FLOWERING TOP OIL BITTER ORANGE OIL CHAMOMILE FLOWER OIL VETIVER OIL 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 ROSEMARY OIL BERGAMOT OIL LEMON OIL BASIL OIL GRAPE SEED OIL PEPPERMINT OIL PEPPERMINT
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Traveling Farmacy Oil Blend Convenience Kit -Outer label Box label
Instructions for use
Information about safe handling and use of the drug product.Peppermint halo Directions for use: apply as desired to entire hairline, creating a halo effect. apply to neck and shoulders for extra cooling and relaxation. avoid eyes and mucous membranes. for prolonged use, consult a doctor. Apply to the following areas: A- Along hairline; B- Neck; C- Shoulders
Gutzy Directions for use: apply directly onto stomach, as desired, and massage in gently. for prolonged use, consult a doctor. Apply to the following areas: A- Stomach
Stress Release Directions for use: to support a sense of balance and calm the spirit, apply to forehead, neck and shoulders. put several drops on a tissue & inhale deeply or insert into pillowcase before bed. add 10-25 drops to a bowl of steaming water; inhale deeply for 5-10 minutes. add 7-12 drops to a full bath & swish to disperse well. for prolonged use, consult a doctor. Apply to the following areas: A- Forehead; B- Neck; C-Shoulders
Brainstorm Directions for use: apply to temples, wrists & palms to promote a sense of balance & awareness. add 10-25 drops to a bowl of steaming water; inhale deeply for 5-10 minutes. myrtle refreshes the mind, while cedarwood grounds & quiets the spirit. clary sage & geranium support feelings of harmony. for prolonged use, consult a doctor. Apply to the following areas: A- Temples; B- Wrists; C- Palms
Energy Directions for use : to refresh the mind, apply a small amount to palms, rub together, then cup hands over nose & mouth & breathe deeply. add 10-25 drops to a bowl of steaming water; inhale deeply for 5-10 minutes. for an uplifting start to the day, massage into soles of feet. apply to wrists, pulse points & around hairline. for prolonged use, consult a doctor. Apply to the following areas: A- Hands
Sleep Well Directions for use: to promote restful sleep, roll onto soles of feet before bed & put on socks to avoid staining sheets. may be used under jaw line or on wrists, throat, temples & pulse points. for prolonged use, consult a doctor. Apply to the following areas; A- Feet; B- Jawline; C- Throat; D- Temples; E- Wrists
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Fortify Keep out of reach of children . If product is swallowed, get medical help or contact a Poison Control Center right away.
Pain Release Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Storage and handling
Information about safe storage and handling of the drug product.Fortify Other information: Close container tightly and store at room temperature away from heat.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API