Otc - Purpose
First aid to help prevent bacterial contamination or skin infections, and temporary relief of pain and itching associated with minor: cuts, scrapes, burns, sunburn, skin irritations.
Mg217coolingburnspray
FDA Label NDC 68093-7319
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wisconsin Pharmacal Company for the product Mg217coolingburnspray (NDC 68093-7319). 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 - purpose, active ingredients, uses, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - 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
Active Ingredients
| Active ingredients | Purpose |
| Benzalkonium Chloride 0.13% | First aid antiseptic |
| Lidocaine HCI USP 4% | Pain reliever |
Uses
First aid to help prevent bacterial contamination or skin infections, and temporary relief of pain and itching associated with minor: cuts, scrapes, burns, sunburn, skin irritations.
Warnings
For external use only.
Otc - Ask Doctor
Ask a doctor before use if you have • deep puncture wounds • animal bites • serious burns
Otc - When Using
When using this product • do not use in or near the eyes • do not apply over large areas of the body or in large quantities • do not apply over raw surfaces or blistered areas • avoid prolonged storage above 40C° (104°F)
Otc - Stop Use
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center immediately.
Directions
Adults and children 2 years and older: clean the affected area, apply a small amount on the area 1 to 3 times daily. • may be covered with a sterile bandage • if bandaged, let dry first.
Other Information
• Do not puncture or incinerate • contents under pressure
Inactive Ingredients
Aloe barbadensis leaf extract (Aloe vera), Camphor, Deionized water, Propylene glycol
Questions Or Comments?
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