PAIN RELEASE- menthol liquid

Pain Release by

Drug Labeling and Warnings

Pain Release by is a Otc medication manufactured, distributed, or labeled by Saje Natural Business Inc., Natures Formulae Health Products Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS Active ingredient

Menthol 0.25%

PURPOSE

Purpose Topical Analgesic

Uses For the temporary relief of pain and itching associated with minor cuts, scrapes, or insect bites.

Warnings

For external use only.

Do not use

• if epileptic 
• with high blood pressure

When using this product,

avoid contact with the eyes

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.

• Not recommended for children under 12 years of age.

Inactive ingredients

Anthemis nobilis flower oil, eucalyptus oil, lavender oil, melaleuca leucadendron cajaput oil, origanum majorana leaf oil, peppermint oil, rosmarinus officinalis (rosemary) leaf oil, and water.

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 CAP AND BOTTLE'S NECK IS BROKEN OR MISSING

SKU 376701

DISPOSAL AND WASTE HANDLING

We support recycling. Please recycle where possible.

Pain Release Topical Analgesic Mist (100 ml)

Saje® Natural Wellness

Pain Release 

Topical Analgesic Mist

3.4 fl. oz. | 100 ml

INGREDIENTS AND APPEARANCE

PAIN RELEASE 
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70983-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.23 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)
WATER (UNII: 059QF0KO0R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70983-005-08	1 in 1 BOX	10/16/2016
1		100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

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(70983-005)