FDA Label for Pain Release

View Indications, Usage & Precautions

DRUG FACTS ACTIVE INGREDIENT
OTC - PURPOSE
WARNINGS
DO NOT USE
WHEN USING THIS PRODUCT,
STOP USE AND ASK A DOCTOR IF
IF PREGNANT OR BREAST-FEEDING,
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
DOSAGE & ADMINISTRATION
INACTIVE INGREDIENTS
OTC - QUESTIONS
PAIN RELEASE 620 G
PAIN RELEASE 120 G
PAIN RELEASE BATH SALT SOAK 620 G
PAIN RELEASE BATH SALT SOAK 120 G

Pain Release Product Label

The following document was submitted to the FDA by the labeler of this product Natures Formulae Health Products Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts Active Ingredient

Menthol 0.16%

Otc - 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.

Otc - 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