MG217COOLINGBURNSPRAY- lidocaine, benzalkonium chloride spray

MG217CoolingBurnSpray by

Drug Labeling and Warnings

MG217CoolingBurnSpray by is a Otc medication manufactured, distributed, or labeled by Wisconsin Pharmacal Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Drug Facts

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.

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

INGREDIENTS AND APPEARANCE

MG217COOLINGBURNSPRAY 
lidocaine, benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68093-7319
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.04 g  in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.013 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68093-7319-1	113 g in 1 CAN; Type 0: Not a Combination Product	04/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/17/2020

Labeler - Wisconsin Pharmacal Company (800873986)

Establishment
Name	Address	ID/FEI	Business Operations
Wisconsin Pharmacal Company		800873986	manufacture(68093-7319) , pack(68093-7319) , label(68093-7319)