Label: ARAMARK BURN- lidocaine hcl spray
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Contains inactivated NDC Code(s)
NDC Code(s): 81238-5100-3 - Packager: Western First Aid Safety DBA Aramark
- 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 June 28, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL – 3 oz. bottle
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INGREDIENTS AND APPEARANCE
ARAMARK BURN
lidocaine hcl sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81238-5100 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) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81238-5100-3 118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 06/15/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/15/2021 Labeler - Western First Aid Safety DBA Aramark (043861524) Registrant - Western First Aid Safety DBA Aramark (043861524) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 MANUFACTURE(81238-5100)