Active Ingredient
Natural Menthol USP 2.4%
Tjz Night-time Topical Pain Relief Balm
FDA Label NDC 73668-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lab-o Corp for the product Tjz Night-time Topical Pain Relief Balm (NDC 73668-001). 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 active ingredient, purpose, uses, warnings, 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
Purpose
Topical analgesic
Uses
The temporary relief of minor aches and pains of muscles and joints.
Warnings
For external use only
Allergy alert: If you are allergic to aspirin or salicylates, consult a doctor before use
When Using This Product
- use only as directed
- avoid contact with eyes and mucous membranes
- wash hands with soap and water after use
- do not apply to wounds, or damaged skin
- do not cover with bandage or apply heat
Stop Use And Ask A Doctor If
- condition worsens
- redness or skin irritation occurs
- symptoms persist for more than 7 days or clear up and occur again within a few days
If Pregnant Or Breast-Feeding
or if you have sensitive skin, ask a healthcare professional before use
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center immediately.
Flammable
Keep away from excessive heat or open flame
Directions
For adults and children over 12, using the applicator tip, massage into affected area before bedtime. For children 12 years of age or younger, consult a physician before use.
Inactive Ingredients
Jojoba Seed Oil*, Beeswax*, Wintergreen Leaf Oil*, Lavender Oil*, Ginger Root Oil*, Camphor
*Organic
Other Information
Store in a cool, dry place, away from heat with lid closed tightly. Contains natural methyl salicylate from wintergreen. Report serious adverse reactions to: TJz Balm PO Box 1778, Boca Raton, FL 33429-1778 USA
Certified Organic by PCO
Company Information
TJzbalm.com
Questions: [email protected]
Product Packaging
TJz balm
Night-time
Topical pain relief balm
Moisturizing and
Soothing
For Jaw, Neck &
Behind Ears
Hands-free,
Massaging tip applicator
A portion of the profits
will be donated to
TMJ Research
0.5 oz (14 g)
* Please review the disclaimer below.
