MG217COOLINGBURNSPRAY- lidocaine, benzalkonium chloride spray 
Wisconsin Pharmacal Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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MG217 Cooling Burn Spray

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.

Drug Facts

Active ingredients

Active ingredientsPurpose
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.

Ask a doctor before use if you have • deep puncture wounds • animal bites • serious burns

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)

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.

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?

1-800-635-3696

Principal Display Panel

label

MG217COOLINGBURNSPRAY 
lidocaine, benzalkonium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68093-7319
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.013 g  in 1 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.04 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68093-7319-1113 g in 1 CAN; Type 0: Not a Combination Product04/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/17/2020
Labeler - Wisconsin Pharmacal Company (800873986)
Establishment
NameAddressID/FEIBusiness Operations
Wisconsin Pharmacal Company800873986manufacture(68093-7319) , pack(68093-7319) , label(68093-7319)

Revised: 1/2022
Document Id: d57c1968-21f4-0c99-e053-2a95a90a37b6
Set id: a3501096-14db-4d1f-e053-2995a90a8947
Version: 2
Effective Time: 20220113
 
Wisconsin Pharmacal Company