Pain Release: Package Insert and Label Information

PAIN RELEASE- menthol oil
Saje Natural Business Inc.

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.

DRUG FACTS Active ingredient

Menthol 1.37%

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

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

´╗┐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

We support recycling. Please recycle where possible.

Pain Release Topical Analgesic Massage Oil

Saje Natural Wellness

Pain Release

Topical Analgesic Massage Oil

1.4 fl.oz | 40ml

Pain release 40ml massage oil label
(click image for full-size original)

Saje Natural Wellness

Pain Release

Topical Analgesic Massage Oil

3.4 fl. oz. |100 ml

PainRelease_100ml
(click image for full-size original)

Saje Natural Wellness

Pain Release

Topical Analgesic Massage Oil

6.8 fl. oz. | 200 ml

image description
(click image for full-size original)
PAIN RELEASE
menthol oil
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70983-007
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 12.18 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CHAMAEMELUM NOBILE FLOWER OIL
EUCALYPTUS OIL
LAVENDER OIL
CAJUPUT OIL
SWEET MARJORAM OIL
PEPPERMINT OIL
APRICOT KERNEL OIL
ROSEMARY OIL
TOCOPHEROL
GRAPE SEED OIL
Product Characteristics
Color white (clear) Score
Shape FREEFORM (oil) Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70983-007-10 1 BOTTLE, DROPPER in 1 BOX contains a BOTTLE, DROPPER
1 200 mL in 1 BOTTLE, DROPPER This package is contained within the BOX (70983-007-10)
2 NDC:70983-007-11 40 mL in 1 BOTTLE, PLASTIC None
3 NDC:70983-007-09 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
3 100 mL in 1 BOTTLE, PLASTIC This package is contained within the BOX (70983-007-09)
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 Operations
Natures Formulae Health Products Ltd. 241385587 manufacture (70983-007)

Revised: 06/2020 Saje Natural Business Inc.

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