Otc - Active Ingredient
Active Ingredient: Menthol 1.25%
Muscle Move Gel
FDA Label NDC 70983-031
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 Wellness Inc. for the product Muscle Move (NDC 70983-031). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - ask doctor, otc - keep out of reach of children, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Topical Analgesic
Indications & Usage
Use(s) For the temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains. Penetrating and cooling pain relief.
Warnings
Warnings
For external use only. Avoid contact with the eyes. Do not apply to wounds or damaged skin. Do not bandage tightly. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
Otc - When Using
For external use only. Avoid contact with the eyes.
Otc - Ask Doctor
If condition worsens, or does not improve within 7 days, consult a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Otc - Stop Use
If condition worsens, or does not improve within 7 days, consult a doctor.
Other Safety Information
IMPORTANT: READ ALL PRODUCT INFORMATION BEFORE USING. KEEP THIS PACKAGE FOR FULL INFORMATION. STORE AT ROOM TEMPERATURE.
Dosage & Administration
Directions
• Adults and children 12 years of age and older: Apply to affected area not more than 3 times daily.
• Not recommended for children under 12 years of age.
Inactive Ingredient
Inactive ingredients: aqua/water/eau, copaifera officinalis (balsam copaiba) resin oil, curcuma longa (turmeric) root oil, eucalyptus oil, glycerin, lysolecithin, pentylene glycol, phenethyl alcohol, propanediol, pullulan, sclerotium gum, silica, sodium phytate, xanthan gum, zingiber officinale (ginger) root oil.
Otc - Questions
Distributed by: Saje Natural Wellness 101-19347 24th Ave Surrey, BC Canada V3S 3S9 | saje.com | @sajewellness | 1-877-ask-saje
Made in Canada
Disposal And Waste Handling
Please recycle where possible.
Recent Major Changes
Recent Major Changes (§ 201.57(a)(5)):
• Boxed Warning
• Indications and Usage: None
• Dosage and Administration: None
• Contraindications: None
• Warnings and Precautions: Added "Do not apply to wounds or damaged skin. Do not bandage tightly." (June 24, 2026)
Package Label.Principal Display Panel
NAME:
Muscle Move
DESCRIPTOR:
Cooling Recovery Gel
Active Ingredient Menthol 1.25%
Use(s) For the temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains. Penetrating and cooling pain relief.
Purpose
Topical Analgesic
Use(s) For the temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains. Penetrating and cooling pain relief.
Warnings
For external use only. Avoid contact with the eyes. Do not apply to wounds or damaged skin. Do not bandage tightly. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
Directions:
• Adults and children 12 years of age and older: Apply to affected area not more than 3 times daily.
• Not recommended for children under 12 years of age.
Inactive ingredients: aqua/water/eau, copaifera officinalis (balsam copaiba) resin oil, curcuma longa (turmeric) root oil, eucalyptus oil, glycerin, lysolecithin, pentylene glycol, phenethyl alcohol, propanediol, pullulan, sclerotium gum, silica, sodium phytate, xanthan gum, zingiber officinale (ginger) root oil.
* Please review the disclaimer below.
