Drug Factsactive Ingredient
Menthol 0.16%
Pain Release Granule
FDA Label NDC 70983-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Saje Natural Business Inc. for the product Pain Release (NDC 70983-004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug factsactive 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., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Saje® Natural Wellness
Pain Release
Pain Relieving Bath Salt Soak
net wt. 4.2 oz. | 120 g
* Please review the disclaimer below.
