Label: COMFORT AND EASE- menthol kit
- NDC Code(s): 70983-016-18
- Packager: Saje Natural Business Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 11, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
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 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
- SWEET COMFORT antitussive (cough suppressant) oil blend rub Drug Facts Active ingredient
- PURPOSE
- Warnings
- Ask doctor before use if you have
- When using this product, do not
- Stop use and ask a doctor if
- If pregnant of breast-feeding,
- Keep out of reach of children.
- Directions
- DOSAGE & ADMINISTRATION
- Other information
- Inactive ingredients
- Sweet Comfort antitussive (cough suppressant) oil blend rub
-
SOOTHING OIL BLEND
INHALE 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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
COMFORT AND EASE
menthol kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70983-016 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70983-016-18 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 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 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 3 SWEET COMFORT
menthol oilProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 24.56 mg in 1 mL Inactive Ingredients Ingredient Name Strength STYRAX BENZOIN RESIN (UNII: FE663Z8IRO) LAVENDER OIL (UNII: ZBP1YXW0H8) LEMON OIL (UNII: I9GRO824LL) TEA TREE OIL (UNII: VIF565UC2G) FRANKINCENSE OIL (UNII: 67ZYA5T02K) PEPPERMINT OIL (UNII: AV092KU4JH) PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) APRICOT KERNEL OIL (UNII: 54JB35T06A) 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 3 of 3 INHALE
other skin care preparationsProduct Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR GRAPE SEED OIL (UNII: 930MLC8XGG) INGR LAVENDER OIL (UNII: ZBP1YXW0H8) INGR LEMON OIL (UNII: I9GRO824LL) INGR PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC) INGR MYRRH OIL (UNII: H74221J5J4) INGR PEPPERMINT OIL (UNII: AV092KU4JH) INGR CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839) 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 - Saje Natural Business Inc. (203413380) Establishment Name Address ID/FEI Business Operations Natures Formulae Health Products Ltd. 241385587 manufacture(70983-016)