Otc - Active Ingredient
Lidocaine HCI 4%
Gurunanda Pain Relief Spray
FDA Label NDC 70708-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gurunanda, Llc. for the product Gurunanda Pain Relief (NDC 70708-101). 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, uses, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Analgesic
Uses
for temporary relief of pain
Warnings
For external use only
Do Not Use
- in large quantities, particularly over raw surfaces or blistered areas
- on wounds or damaged skin
- with a heating pad
- if you are allergic to any ingredients of this product
Ask A Doctor Before Use If You Have
sensitive skin or kidney problems
When Using This Product
- use only as directed. Read and follow all directions and warnings on this label
- avoid contact with eyes and mucous membranes
- do not apply to irritated skin or if excessive irriation develops
- avoid spraying on face
- avoid inhalation of spray
- avoid applying to skin folds
- do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use
- do not use at the same time as other topical analgesic
Stop Use And Ask A Doctor If
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
- you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222)
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: Do not use. Consult a doctor
Other Information
- Do not use if printed seal is broken or missing
- Store the product in a cool, dry place, away from direct sunlight and excessive moisture
Inactive Ingredients
Water, Magnesium Chloride, PEG-40 Hydrogenated Castor Oil, Benzyl Alcohol, Arnica Montana Flower Extract, Ginger Oil, Peppermint Oil, Cholecalciferol (Vitamin D3), Wintergreen Oil, D-Alpha Tocopherol (Vitamin E), Black Pepper Oil, Menaquinone-7 (Vitamin K2), Caprylic/Capric/Lauric Triglyceride
* Please review the disclaimer below.
