Active Ingredients
Camphor 5.5%
Menthol 16%
Menthol Plus Camphor Pain Relief Spray
FDA Label NDC 71101-982
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Veridian Healthcare for the product Menthol Plus Camphor Pain Relief (NDC 71101-982). 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 breastfeeding, 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
Pain relieving spray
Uses
for temporary relief of minor pain and associated with:
- simple backache
- arthritis
- strains
- bruises
- sprains
- provides penetrating pain relief
Warnings
For external use only
Flammable Do not use while smoking or near heat of flame. Do not use while smoking. Do not punture or incinerate. Contents under pressure.
When Using This Product
- avoid contact with eyes
- do not apply to wounds or damage skin
- do not bandage tightly
Stop Use And Ask A Doctor If
- condition worsens
- or if symptoms persist for more than 7 days or clear up and reoccur within a few days.
If Pregnant Or Breastfeeding
ask a health professional before use
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- adults and children 2 years and older:apply to affected area not more than 3 to 4 times daily.
- children under 2 years of age:do not use, ask a doctor
Other Information
- Store out of direct sunlight, in a cool dry well-ventilated area. Do not store at temperature above 120F (49C)
Inactive Ingredients
boswellia serrata resin extract, butylene glycol, dimethyl sulfone, gentiana scabra extract, isopropyl myristate, methyl lactate, propylene glycol, rosmarinus officinalis (rosemary) leaf extract, SD alcohol, srephania tetrandra extract, tocopheryl acetate, vanillyl butyl ether, water
* Please review the disclaimer below.
