Label: ROLLING FARMACY- menthol kit
- NDC Code(s): 70983-015-17
- Packager: Saje Natural Business Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 18, 2024
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SPL UNCLASSIFIED SECTION
The need for wellness doesn't stop when you're on the go. Keep this convenient collection of three of our favourit roll-ons close at hand, wherever your journey takes you. Keep on rolling.
Kit Contains 3 Saje Favorites:
FORTIFY antitussive (cough suppressant) oil blend rub
peppermint halo COOLING & SOOTHING OIL BLEND FOR THE HEAD
gutzy SOOTHING BELLY MASSAGE 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 | 500-88 E. 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
GET READY FOR WELLNESS
SKU 22250301
- 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
- FORTIFY antitussive (cough suppressant) oil blend rub
-
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.
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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.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ROLLING FARMACY
menthol kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70983-015 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70983-015-17 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 1 of 3 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 2 of 3 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 3 of 3 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 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(70983-015)