Label: LIDOCAINE HYDROCHLORIDE liquid
- NDC Code(s): 61010-5100-4, 61010-5100-5
- Packager: Safetec of America, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 7, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
- Warnings
- Directions
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Inactive ingredients
aloe vera, germaben II, propylene glycol, purified water
Manufactured by SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215 800-456-7077 www.safetec.com
PAIN RELIEF – Burn Spray
Safetec of AmericaDisclaimer: 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.
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- PRINCIPAL DISPLAY PANEL – 3 oz. bottle
- PRINCIPAL DISPLAY PANEL – 2 oz. bottle
- PRINCIPAL DISPLAY PANEL – 4 oz. bottle
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INGREDIENTS AND APPEARANCE
LIDOCAINE HYDROCHLORIDE
lidocaine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61010-5100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61010-5100-4 59.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 08/02/2011 2 NDC:61010-5100-5 118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 08/02/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 08/02/2011 Labeler - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 manufacture(61010-5100)