Label: BURN RELIEF- lidocaine spray
-
Contains inactivated NDC Code(s)
NDC Code(s): 24385-777-04 - Packager: Amerisource Bergen
- 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 July 23, 2018
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
For external use only.
Flammable: Do not use near heat, flame, or while smoking.
Do not use in large quantities, particularly over raw surfaces or blistered areas.
When using this product • keep away from face to avoid breathing it. • avoid
contact with eyes. • use only as directed. • do not puncture or incinerate.
Contents under pressure. Do not store at temperatures above 120ºF.
If condition worsens or if symptoms persist for more than 7 days or clear up and
occur again within a few days, discontinue use of this product and consult a doctor. - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- Questions? 610-727-7000
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BURN RELIEF
lidocaine sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24385-777 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 (UNII: V5VD430YW9) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) 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:24385-777-04 128 g in 1 CAN; Type 0: Not a Combination Product 03/15/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/15/2012 Labeler - Amerisource Bergen (007914906) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(24385-777) , label(24385-777)