Label: MG217COOLINGBURNSPRAY- lidocaine, benzalkonium chloride spray
- NDC Code(s): 68093-7319-1
- Packager: Wisconsin Pharmacal Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 13, 2022
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- Drug Facts
For external use only.
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.
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
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 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 Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) 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)