PAIN RELEASE- menthol granule 
Natures Formulae Health Products Ltd.

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.

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Pain Release Bath Salt Soak (620 g, 120 g)

DRUG FACTS

Active ingredient

Menthol 0.16%

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

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

      not more than 3 to 4 times daily.

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.

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

image description

Pain Release Bath Salt Soak 120 g

Saje® Natural Wellness

Pain Release 

Pain Relieving Bath Salt Soak

net wt. 4.2 oz. | 120 g

image description

PAIN RELEASE 
menthol granule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69204-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69204-005-06620 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/16/2016
2NDC:69204-005-071 in 1 PACKET10/16/2016
2120 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/16/2016
Labeler - Natures Formulae Health Products Ltd. (241385587)
Establishment
NameAddressID/FEIBusiness Operations
Natures Formulae Health Products Ltd.241385587manufacture(69204-005)

Revised: 10/2016
Document Id: 781d3c8d-7b71-e973-e053-2991aa0aaa78
Set id: 781d3c8d-7b70-e973-e053-2991aa0aaa78
Version: 1
Effective Time: 20161016
 
Natures Formulae Health Products Ltd.