Label: POCKET FARMACY- menthol kit
- NDC Code(s): 70983-014-16
- Packager: Saje Natural Business Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 18, 2024
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SPL UNCLASSIFIED SECTION
Take this convenient pouch with you everywhere you go to combat everyday challenges and enhance your day.
Kit Contains 5 Saje Favorites:
PAIN RELEASE topical analgesic oil blend
FORTIFY antitussive (cough suppressant) oil blend rub
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
LIFT HERE TO CONTINUE TO READ IMPORTANT PRODUCT INFORMATION ON ALL OIL BLENDS
Distributed by: SAJE NATURAL WELLNESS | 22 East 5th Ave Vancouver, BC Canada, V5T 1G8 | saje.com | 1-877-275-7253 | Made by our friends in Canada
We support recycling. Please recycle where possible
SKU 22282401
- PAIN RELEASE topical analgesic oil blend Drug Facts Active ingredient
- PURPOSE
- Warnings
- Do not use
- When using this product,
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- DOSAGE & ADMINISTRATION
- Inactive ingredients
- PAIN RELEASE topical analgesic oil blend
- FORTIFY antitussive (cough suppressant) oil blend rub Drug Facts Active ingredient
- 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
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- DOSAGE & ADMINISTRATION
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
-
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, 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
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INGREDIENTS AND APPEARANCE
POCKET FARMACY
menthol kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70983-014 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70983-014-16 1 in 1 KIT 10/16/2016 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, DROPPER 10 mL Part 2 1 BOTTLE, DROPPER 10 mL Part 3 1 BOTTLE, DROPPER 10 mL Part 4 1 BOTTLE, DROPPER 10 mL Part 5 1 BOTTLE, DROPPER 10 mL Part 1 of 5 PAIN RELEASE
menthol oilProduct 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 10 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 Drug M017 10/16/2016 Part 2 of 5 FORTIFY
menthol oilProduct 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 10 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 Drug M012 10/16/2016 Part 3 of 5 PEPPERMINT HALO
other fragrance preparations [fragrance 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 10 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 fragrance preparations [fragrance 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 10 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 fragrance preparations [fragrance 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 10 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 Drug M012 10/16/2016 Labeler - Saje Natural Business Inc. (080465432) Establishment Name Address ID/FEI Business Operations Natures Formulae Health Products Ltd. 241385587 manufacture(70983-014)