Comfort And Ease
FDA Label NDC 70983-016

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Saje Natural Business Inc. for the product Comfort And Ease (NDC 70983-016). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, fortify antitussive (cough suppressant) oil blend rubdrug factsactive ingredient, otc - purpose, warnings, do not use, ask doctor before use if you have, when using this product, do not, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

GET READY FOR WELLNESS

Reach for this convenient trio of oil blends to support your wellness, naturally. 

Kit Contains 3 popular saje oil blends:

FORTIFY antitussive (cough suppressant) oil blend rub

SWEET COMFORT antitussive (cough suppressant) oil blend rub

inhale SOOTHING OIL BLEND FOR DEEP BREATHING

IMPORTANT: FOR EACH PRODUCT, READ ALL PRODUCT INFORMATION ON OUTER AND INNER BOX FLAP BEFORE USING.  KEEP THIS PACKAGE FOR FULL INFORMATION.

Distributed by: SAJE NATURAL WELLNESS | 500-88 E. Pender St. Vancouver, BC Canada, V6A 3X3 | saje.com | 1-877-275-7253 | Made by our friends in Canada

LIFT HERE TO CONTINUE TO READ IMPORTANT PRODUCT INFORMATION ON ALL OIL BLENDS

DO NOT USE IF SECURITY SEAL AROUND BOTTLES IS BROKEN OR MISSING.

We support recycling. Please recycle where possible

SKU 22250001

Fortify Antitussive (Cough Suppressant) Oil Blend Rubdrug Factsactive Ingredient

Menthol 2.7%

Otc - Purpose

Purpose Antitussive (Cough Suppressant)

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.

Purpose Antitussive (Cough Suppressant)

Uses Temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants. Suppresses your cough to help you get to sleep. 

Warnings

For external use only.  Do not that by mouth or place in nostrils.

Flammable.  Keep away from fire or flame

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 Doctor Before Use If You Have

  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucus).
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    • cough accompanied by excessive phlegm (mucus)
    • epilepsy

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.
    • heat
    • microwave
    • use near an open flame
    • add to hot water or any container where heating water.  May cause splattering and result in burns. 
    • sun tan/use tanning beds for 3-4 days after use

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.
  • 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.

Keep Out Of Reach Of Children.

If product is swallowed, get medical help or contact a Poison Control Center right away. 

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • See important warnings under 'When using this product'
  • Adults and children 12 years or older: 
  • rub on throat and chest in a  thick layer
  • cover with warm cloth if desired
  • clothing should be loose about throat and chest to help vapors reach the nose and mouth
    • See important warnings under 'When using this product'
    • 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

Dosage & Administration

  • use up to three times daily or as directed by a doctor
  • Children under 12 years of age: ask a doctor.
    • use up to three times daily or as directed by a doctor.
    • Children under 12 years of age: ask a doctor.

Other Information

Close container tightly and store at room temperature away from heat .

  • Close container tightly and store at room temperature away from heat.

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. 

Benzoin, lavender oil, lemon oil, melaleuca alternifolia (tea tree) leaf oil, olibanum, peppermint oil, pine needle oil, and prunus armeniaca (apricot) kernel oil

Fortify Antitussive (Cough Suppressant) Oil Blend Rub

Apply to the following areas, as directed:

A - Throat

B - Chest

Sweet Comfort Antitussive (Cough Suppressant) Oil Blend Rubdrug Factsactive Ingredient

Menthol 2.76%

If Pregnant Of Breast-Feeding,

do not use this product.

Sweet Comfort Antitussive (Cough Suppressant) Oil Blend Rub

Apply to the following areas, as directed: 

A - Throat

B - Chest

Soothing Oil Blendinhale Soothing Oil Blend For Deep Breathing

Directions for use: Used in aromatherapy to promote peaceful breaths. Apply to forehead and sinus areas, avoiding eyes and mucous membranes. Use on skin to soothe dry areas or add 10-20 drops to a bath. For prolonged use, consult a doctor.

Ingredients: Vitis vinifera (grape) seed oil, lavandula angustifolia (lavender) oil, citrus limon (lemon) peel oil, pelargonium graveolens oil, commiphora myrrha oil, mentha piperita (peppermint) oil, and anthemis nobilis flower oil.

Warnings: Keep out of reach of children. For external use only. if swallowed, seek urgent care/call poison control. If epileptic, consult a doctor before use. 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.

Apply to the following areas:

A - Forehead

B - Sinus Area

Package Label.Principal Display Panel

COMFORT & EASE
oil blend convenience kit

2 ANTITUSSIVE (COUGH SUPPRESSANT) OIL BLEND RUBS X 0.2 FL. OZ. | 6 mL EA

1 OIL BLEND 0.2 FL. OZ. | 6 mL

Saje® Natural Wellness

Comfort & Ease Box (Comfort   Ease Otc Box Usa Final 01)

Comfort & Ease Box (Comfort Ease Otc Box Usa Final 01)

* Please review the disclaimer below.