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Pain Release by Saje Natural Business Inc.

Medically reviewed on October 3, 2016

Dosage form: oil
Ingredients: MENTHOL 17.62mg in 1mL
Labeler: Saje Natural Business Inc.
NDC Code: 70983-006

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.

Pain Release Oil Blend (30 ml, 10 ml, 6 ml)

IMPORTANT: READ ALL PRODUCT INFORMATION BEFORE USING.  KEEP THIS PACKAGE FOR FULL INFORMATION. 

DRUG FACTS

Active ingredient

Menthol 1.98%

Purpose Topical Analgesic

Uses For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, 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 

      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 vitis vinifera (grape) seed oil. 

Questions?

1-877-275-7253

´╗┐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 30 ml

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

SKU 10301

Pain Release 10 ml

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

SKU 431201

Pain Release 6 ml

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

SKU 442501

Pain Release Topical Analgesic Oil Blend 30 ml

Saje® Natural Wellness

Pain Release

Topical Analgesic Oil Blend

1 fl. oz. | 30 ml

Pain Release Topical Analgesic Oil Blend 10 ml

Saje® Natural Wellness

Pain Release

Topical Analgesic Oil Blend

0.34 fl. oz. | 10 ml

Pain Release Topical Analgesic Oil Blend 6 ml

Saje® Natural Wellness

Pain Release

Topical Analgesic Oil Blend

0.2 fl. oz. | 6 ml

PAIN RELEASE 
menthol oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70983-006
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL17.62 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CHAMAEMELUM NOBILE FLOWER OIL 
EUCALYPTUS OIL 
LAVENDER OIL 
CAJUPUT OIL 
SWEET MARJORAM OIL 
PEPPERMINT OIL 
ROSEMARY OIL 
GRAPE SEED OIL 
Product Characteristics
Colorwhite (clear) Score    
ShapeFREEFORM (oil) Size
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:70983-006-031 BOTTLE, DROPPER in 1 BOX
130 mL in 1 BOTTLE, DROPPER
2NDC:70983-006-041 BOTTLE, DROPPER in 1 BOX
210 mL in 1 BOTTLE, DROPPER
3NDC:70983-006-051 BOTTLE, DROPPER in 1 BOX
36 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/16/2016
Labeler - Saje Natural Business Inc. (203413380)
Establishment
NameAddressID/FEIOperations
Natures Formulae Health Products Ltd.241385587manufacture(70983-006)

 
Saje Natural Business Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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