HOME FARMACY- menthol kit

Home Farmacy by

Drug Labeling and Warnings

Home Farmacy by is a Otc medication manufactured, distributed, or labeled by Natures Formulae Health Products Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

GET READY FOR WELLNESS

A must-have natural farmacy for every home, including five favorite oil blends.  Find natural solutions for everyday challenges. 

Kit Contains 5 Saje Favorites:

FORTIFY antitussive (cough suppressant) oil blend rub

PAIN RELEASE topical analgesic oil blend

peppermint halo COOLING & SOOTHING OIL BLEND FOR THE HEAD

gutzy SOOTHING BELLY MASSAGE BLEND

stress release SOOTHING OIL BLEND

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

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

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

We support recycling. Please recycle where possible.

SKU 22270501

Lift here to continue to read important product information on all oil blends.

FORTIFY antitussive (cough suppressant) oil blend rub  Drug Facts  Active ingredient 

Menthol 2.7%

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.

Warnings

For external use only.

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 breastfeeding,

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.

Directions

• See important warnings under 'When using this product'
• Adults and children 12 years and older: 
• rub on 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: ask a doctor.

Other information

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. 

FORTIFY antitussive (cough suppressant) oil blend rub

Apply to the following areas, as directed:

A - Throat

B - Chest

PAIN RELEASE topical analgesic oil blend Drug Facts Active ingredient 

Menthol 1.98%

PURPOSE

Purpose Topical Analgesic

Uses For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains

Warnings

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.

Keep out of reach of children.

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

Directions

• Adults and children 12 years of age and older: Apply to affected area

DOSAGE & ADMINISTRATION

     not more than 3 to 4 times daily

• Children under 12 years of age: Consult a doctor.

Inactive ingredients

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.

PAIN RELEASE topical analgesic oil blend

Apply to muscles & joints experiencing minor aches & pains, as directed:

A - Shoulders

B - Neck

C - Back (upper/middle/lower)

D - Elbows

E - Hands

F - Soles of Feet

G - Hips

H - Thighs

I - Knees

J - Calves

SOOTHING OIL BLENDS PEPPERMINT HALO cooling & soothing oil blend for the head

Apply to the following areas:

A - Along hairline

B - Neck

C - Shoulders

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.

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.

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 soothing belly massage blend

Apply to the following areas:

A - Stomach

Directions for use: Treat your tummy to an aromatic massage with soothing and comforting peppermint, fennel, chamomile, and black pepper. apply directly onto stomach, as desired, and massage in gently. For prolonged use, consult a doctor.

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.

Warnings:

• 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 soothing oil blend

Apply to the following areas:

A - Forehead

B - Neck

C - Shoulders

Directions for use: To support a sense of balance & calm the spirit, apply to forehead, neck & 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.

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.

Warnings:

• 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.
• Contains phototoxic orange essential oil; do not sun tan/use tanning beds for 3-4 days after use.

PRINCIPAL DISPLAY PANEL

Saje® Natural Wellness

home farmacy

OIL BLEND CONVENIENCE BAR

1 ANTITUSSIVE (COUGH SUPPRESSANT) OIL BLEND RUB 0.2 FL.OZ. | 6 mL

1 TOPICAL ANALGESIC OIL BLEND 0.2 FL.OZ. | 6 mL

3 OIL BLENDS X 0.2 FL.OZ. | 6 mL

INGREDIENTS AND APPEARANCE

HOME FARMACY 
menthol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69204-013

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69204-013-14	1 in 1 KIT	10/16/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, DROPPER	6 mL
Part 2	1 BOTTLE, DROPPER	6 mL
Part 3	1 BOTTLE, DROPPER	6 mL
Part 4	1 BOTTLE, DROPPER	6 mL
Part 5	1 BOTTLE, DROPPER	6 mL

Part 1 of 5

FORTIFY 
menthol oil

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	24.03 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CINNAMON OIL (UNII: E5GY4I6YCZ)
EUCALYPTUS OIL (UNII: 2R04ONI662)
TEA TREE OIL (UNII: VIF565UC2G)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
PEPPERMINT OIL (UNII: AV092KU4JH)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
ROSEMARY OIL (UNII: 8LGU7VM393)
GRAPE SEED OIL (UNII: 930MLC8XGG)

Product Characteristics
Color	white (clear)	Score
Shape	FREEFORM (oil)	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		6 mL in 1 BOTTLE, DROPPER; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/16/2016

Part 2 of 5

PAIN RELEASE 
menthol oil

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	17.62 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LAVENDER OIL (UNII: ZBP1YXW0H8)
CAJUPUT OIL (UNII: J3TO6BUQ37)
SWEET MARJORAM OIL (UNII: ICH7BE016E)
PEPPERMINT OIL (UNII: AV092KU4JH)
ROSEMARY OIL (UNII: 8LGU7VM393)
GRAPE SEED OIL (UNII: 930MLC8XGG)

Product Characteristics
Color	white (clear)	Score
Shape	FREEFORM (oil)	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		6 mL in 1 BOTTLE, DROPPER; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/16/2016

Part 3 of 5

PEPPERMINT HALO 
other skin care preparations

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	PEPPERMINT OIL (UNII: AV092KU4JH)
INGR	EUCALYPTUS OIL (UNII: 2R04ONI662)
INGR	CAJUPUT OIL (UNII: J3TO6BUQ37)
INGR	ROSEMARY OIL (UNII: 8LGU7VM393)
INGR	LAVENDER OIL (UNII: ZBP1YXW0H8)
INGR	VETIVER OIL (UNII: 9M9P32M01L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		6 mL in 1 BOTTLE, DROPPER; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Part 4 of 5

GUTZY 
other skin care preparations

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	GRAPE SEED OIL (UNII: 930MLC8XGG)
INGR	FENNEL OIL (UNII: 59AAO5F6HT)
INGR	PEPPERMINT OIL (UNII: AV092KU4JH)
INGR	CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
INGR	BLACK PEPPER OIL (UNII: U17J84S19Z)
INGR	MYRRH OIL (UNII: H74221J5J4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		6 mL in 1 BOTTLE, DROPPER; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Part 5 of 5

STRESS RELEASE 
other skin care preparations

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	GRAPE SEED OIL (UNII: 930MLC8XGG)
INGR	LAVENDER OIL (UNII: ZBP1YXW0H8)
INGR	ORANGE OIL (UNII: AKN3KSD11B)
INGR	CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
INGR	VETIVER OIL (UNII: 9M9P32M01L)
INGR	PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
INGR	CLARY SAGE OIL (UNII: 87L0D4U3M0)
INGR	MYRTLE LEAF OIL (UNII: 4ZP3Q1OY08)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		6 mL in 1 BOTTLE, DROPPER; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/16/2016

Labeler - Natures Formulae Health Products Ltd. (241385587)

Establishment
Name	Address	ID/FEI	Business Operations
Natures Formulae Health Products Ltd.		241385587	manufacture(69204-013)