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NDC 68093-7319-01 MG217CoolingBurnSpray .013; .04 g/g; g/g Details

MG217CoolingBurnSpray .013; .04 g/g; g/g

MG217CoolingBurnSpray is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Wisconsin Pharmacal Company. The primary component is BENZALKONIUM CHLORIDE; LIDOCAINE.

Product Information

NDC	68093-7319
Product ID	68093-7319_d57c1968-21f4-0c99-e053-2a95a90a37b6
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	MG217CoolingBurnSpray
Proprietary Name Suffix	n/a
Non-Proprietary Name	LIDOCAINE, BENZALKONIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	.013; .04
Active Ingredient Units	g/g; g/g
Substance Name	BENZALKONIUM CHLORIDE; LIDOCAINE
Labeler Name	Wisconsin Pharmacal Company
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 68093-7319-01 (68093731901)

Pricing Information	N/A
NDC Package Code	68093-7319-1
Billing NDC	68093731901
Package	113 g in 1 CAN (68093-7319-1)
Marketing Start Date	2020-04-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a3501096-14db-4d1f-e053-2995a90a8947 Details

SPL UNCLASSIFIED SECTION

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

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

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

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

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

Labeler - Wisconsin Pharmacal Company (800873986)

Name	Address	ID/FEI	Business Operations
Establishment
Wisconsin Pharmacal Company		800873986	manufacture(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