NDC | 24385-777-04 |
Set ID | 77072d8c-080d-4a3d-8733-ea25aee765cf |
Category | HUMAN OTC DRUG LABEL |
Packager | Amerisource Bergen |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART348 |
- 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
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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)