Label: ROAD TO WELLNESS- menthol kit
- NDC Code(s): 70983-017-19
- Packager: Saje Natural Business Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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.
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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
Kit Contains 3 SAJE FAVORITES:
TRAUMA LESS topical analgesic ointment
PAIN RELEASE topical analgesic oil blend
peppermint halo COOLING & SOOTHING OIL BLEND FOR THE HEAD
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 THE FOLLOWING SECURITY FEATURES ARE BROKEN OR MISSING:
SEAL AROUND TIN (OINTMENT) | SEAL AROUND BOTTLE (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
SKU 22280201
LIFT HERE TO CONTINUE TO READ IMPORTANT PRODUCT INFORMATION ON ALL PRODUCTS.
GET READY FOR WELLNESS
- Drug Facts Active ingredient
- PURPOSE
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- DOSAGE & ADMINISTRATION
- Inactive ingredients
- 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
-
SOOTHING OIL BLEND
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.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ROAD TO WELLNESS
menthol kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70983-017 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70983-017-19 1 in 1 KIT 10/16/2016 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 CANISTER 13.5 g Part 2 1 BOTTLE, DROPPER 6 mL Part 3 1 BOTTLE, DROPPER 6 mL Part 1 of 3 TRAUMA LESS
menthol ointmentProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 12.7 mg in 1 g Inactive Ingredients Ingredient Name Strength ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) YELLOW WAX (UNII: 2ZA36H0S2V) OLIVE OIL (UNII: 6UYK2W1W1E) PEPPERMINT OIL (UNII: AV092KU4JH) Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 13.5 g in 1 CANISTER; 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 2 of 3 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 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 3 PEPPERMINT HALO
other skin care preparationsProduct 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/16/2016 Labeler - Saje Natural Business Inc. (203413380) Establishment Name Address ID/FEI Business Operations Natures Formulae Health Products Ltd. 241385587 manufacture(70983-017)