Active Ingredients
Camphor 11%
Menthol 11%
Gurunanda Pain Relief Ointment
FDA Label NDC 70708-937
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 70708-937). 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 ingredients, purpose, uses, warnings, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, or if you have sensitive skin, 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
For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthirtis, bruises, strains and sprains
Warnings
For external use only.
When Using This Product
use only as directed, avoid contact with eye and mucous membranes, do not apply to wounds, damaged or irritated skin, do not bandage or cover with wrap or heating pad, do not use 1 hour prior to bathing or within 30 minutes after bathing
Stop Use And Ask A Doctor If
- condition worsens
- severe skin irritaiton occurs
- pain persists for more than 7 days
- pain clears up and then recurs a few days later
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 (1-800-222-1222).
Directions
- for adults and children over 12 years: rub well on the affected area. Repeat 3 to 4 times daily
- for children 12 years of age or younger: consult a doctor before use
- Children under 2 years of age: Do not use
Other Information
This product may cause allergic reaction on some individuals. Test on a small area before use. Do not use if printed seal is broken or missing
Inactive Ingredients
Cajuput Oil, Cassia Oil, Clove Oil, Dementholized Mint Oil, Paraffin Base
Package Label.Principal Display Panel
08937 (08937.1)
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