Label: BURN- lidocaine hydrochloride spray
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Contains inactivated NDC Code(s)
NDC Code(s): 62985-5082-1 - Packager: First Aid Only, Inc
- Category: HUMAN OTC DRUG LABEL
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 August 13, 2014
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- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BURN
lidocaine hydrochloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62985-5082 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 g in 1 L 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:62985-5082-1 0.0887 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 08/13/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/13/2014 Labeler - First Aid Only, Inc (196551634) Registrant - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 MANUFACTURE(62985-5082)