Label: MEDLINE- benzalkonium chloride, lidocain hydrochloride spray
- NDC Code(s): 53329-918-04
- Packager: Medline Industries, LP
- 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 July 26, 2022
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- Active ingredients
For external use only.
Do not use
- in the eyes or apply over large areas of the body
- longer than 1 week, unless directed by a doctor
- in large quantities, particularly over raw surfaces or blistered areas
When using this product
- contents under pressure
- do not puncture or incinerate
- store at temperatures between 45°-130°F (7°-54°C), avoid excessive heat
- Inactive ingredients
- Questions or comments?
- Manufacturing Information
- Package Label
INGREDIENTS AND APPEARANCE
benzalkonium chloride, lidocain hydrochloride spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-918 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 g LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 4 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM HYDROXIDE (UNII: 55X04QC32I) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-918-04 113 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/01/2021 Labeler - Medline Industries, LP (025460908)