Label: ANTISEPTIC- alcohol, lidocaine hydrochloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 55550-100-02 - Packager: Total Resources International
- 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 14, 2020
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
- Warnings
- Directions
- Inactive ingredients
- Principal Display Panel – Pouch Label
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INGREDIENTS AND APPEARANCE
ANTISEPTIC
alcohol, lidocaine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55550-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol 500 mg in 1 g lidocaine hydrochloride (UNII: V13007Z41A) (lidocaine - UNII:98PI200987) lidocaine hydrochloride anhydrous 20 mg in 1 g Inactive Ingredients Ingredient Name Strength benzalkonium chloride (UNII: F5UM2KM3W7) menthol (UNII: L7T10EIP3A) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55550-100-02 0.8 g in 1 POUCH; Type 0: Not a Combination Product 01/14/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 01/14/2020 Labeler - Total Resources International (790160535)