Pain Release (Menthol) Oil [Natures Formulae Health Products Ltd.] -

PAIN RELEASE (MENTHOL) OIL [NATURES FORMULAE HEALTH PRODUCTS LTD.]
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NDC	69204-008-10, 69204-008-11
Set ID	781dfd66-f006-a2d7-e053-2991aa0a170c
Category	HUMAN OTC DRUG LABEL
Packager	Natures Formulae Health Products Ltd.
Generic Name
Product Class
Product Number
Application Number	PART348

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DRUG FACTS Active ingredient

Menthol 1.37%
PURPOSE

Purpose Topical Analgesic

Uses For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, brusies, 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 away.
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, prunus armeniaca (apricot) kernel oil, rosmarinus officinalis (rosemary) leaf oil, tocopherol, and vitis vinifera (grape) seed oil.
Questions?

1-877-275-7253
SPL UNCLASSIFIED SECTION

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

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

SKU 415401
DISPOSAL AND WASTE HANDLING

We support recycling. Please recycle where possible.
Pain Release Topical Analgesic Massage Oil

Saje® Natural Wellness

Pain Release

Topical Analgesic Massage Oil

6.8 fl. oz. | 200 ml and 1.4 fl.oz | 40ml

INGREDIENTS AND APPEARANCE

PAIN RELEASE
menthol oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69204-008
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	12.18 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
ROSEMARY OIL (UNII: 8LGU7VM393)
TOCOPHEROL (UNII: R0ZB2556P8)
GRAPE SEED OIL (UNII: 930MLC8XGG)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69204-008-10	1 in 1 BOX	10/16/2016
1		200 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC:69204-008-11	40 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/16/2016

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

Labeler - Natures Formulae Health Products Ltd. (241385587)

Name	Address	ID/FEI	Business Operations
Establishment
Natures Formulae Health Products Ltd.		241385587	manufacture(69204-008)

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Medic

PAIN RELEASE (MENTHOL) OIL [NATURES FORMULAE HEALTH PRODUCTS LTD.]

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