Label: BURN RELIEF- lidocaine 0.5% spray
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Contains inactivated NDC Code(s)
NDC Code(s): 64048-5115-4 - Packager: Product Quest Mfg
- 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 23, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient Purpose
- PURPOSE
- Uses
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Warnings
For external use only
When using this product
- keep out of your eyes
- use only as directed
- do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120F.
- Directions
- Inactive ingredients
- Questions and comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BURN RELIEF
lidocaine 0.5% sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64048-5115 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Lidocaine (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) Lidocaine 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) Diazolidinyl Urea (UNII: H5RIZ3MPW4) Disodium Cocoamphodipropionate (UNII: 6K8PRP397M) EDETATE DISODIUM (UNII: 7FLD91C86K) Glycerin (UNII: PDC6A3C0OX) Methylparaben (UNII: A2I8C7HI9T) Propylene Glycol (UNII: 6DC9Q167V3) Propylparaben (UNII: Z8IX2SC1OH) ALCOHOL (UNII: 3K9958V90M) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64048-5115-4 127 g in 1 CAN; Type 0: Not a Combination Product 02/06/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/06/2014 Labeler - Product Quest Mfg (927768135) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(64048-5115) , label(64048-5115)