PAIN RELEASE- menthol granule

Pain Release by

Drug Labeling and Warnings

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

Drug Details [pdf]

DRUG FACTS Active ingredient

Menthol 0.16%

PURPOSE

Purpose External Analgesic

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

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 by dissolving 2 teaspoons of salt soak in warm water and soaking 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, cinnamomum camphora (camphor) bark oil, corn starch, epsom salt, eucalyptus oil, lavender oil, origanum majorana leaf oil, peppermint oil, rosmarinus officinalis (rosemary) leaf oil, sea salt, and sodium bicarbonate.

QUESTIONS

Distributed by: SAJE NATURAL WELLNESS 500-88 E. Pender St. Vancouver, BC Canada V6A 3X3 | saje.com | 1-877-275-7253 | Made in Canada

Pain Release 620 g

DO NOT USE IF SAJE SEAL ON BOTTLE'S OPENING IS BROKEN OR MISSING.

SKU 427901

Pain Release 120 g

DO NOT USE IF TEAR NOTCH SECURITY SEAL ON ZIPPERED BAG INSIDE IS DAMAGED OR MISSING

SKU 423501

Pain Release Bath Salt Soak 620 g

Saje® Natural Wellness

Pain Release 

Pain Relieving Bath Salt Soak

net wt. 21.9 oz. | 620 g

Pain Release Bath Salt Soak 120 g

Saje® Natural Wellness

Pain Release 

Pain Relieving Bath Salt Soak

net wt. 4.2 oz. | 120 g

INGREDIENTS AND APPEARANCE

PAIN RELEASE 
menthol granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69204-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
CAMPHOR OIL (UNII: 75IZZ8Y727)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LAVENDER OIL (UNII: ZBP1YXW0H8)
SWEET MARJORAM OIL (UNII: ICH7BE016E)
PEPPERMINT OIL (UNII: AV092KU4JH)
ROSEMARY OIL (UNII: 8LGU7VM393)
SEA SALT (UNII: 87GE52P74G)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69204-005-06	620 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/16/2016
2	NDC: 69204-005-07	1 in 1 PACKET	10/16/2016
2		120 g in 1 POUCH; 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 - Natures Formulae Health Products Ltd. (241385587)

Establishment
Name	Address	ID/FEI	Business Operations
Natures Formulae Health Products Ltd.		241385587	manufacture(69204-005)