Label: BITE AND STING RELIEF GNP- benzocaine spray
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Contains inactivated NDC Code(s)
NDC Code(s): 46122-653-34 - Packager: Amerisource Bergen LLC
- 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 January 17, 2022
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- Official Label (Printer Friendly)
- Active ingredient Purpose
- PURPOSE
- Uses
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Warnings
For external use only.
Flammable: Do not use while smoking or near heat or flame
When using this product• avoid contact with the eyes• use only as directed.• do not puncture or incinerate.Contents under pressure.
Do not store at temperatures above 120°F.
Stop use and ask a doctor if• condition worsens• symptoms persist for more than 7 days or clear up and occur again within a few days. - Keep out of the reach of children.
- Directions
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Inactive ingredients
Aloe Barbadensis Leaf Juice Extract, Ascorbic Acid, Camphor, Chamomilla Recutita (Matricaria) Flower, Extract, Cholecalciferol, Diisopropyl Adipate, Eugenia Caryophyllus (Clove) Flower Oil, Fragrance, Mentha Piperita ( Peppermint) Oil, Octyldodecanol, Olea Europaea (Olive) Fruit Oil,PE -8 Dimethicone, Propylene lycol, Pyridoxine HCI, Retinyl Palmitate, SD Alcohol 40, Silica, Sodium Propoxyhydroxypropyl Thiosulfate Silica,
Tocopheryl Acetate, Zea Mays (Corn) Oil.
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BITE AND STING RELIEF GNP
benzocaine sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-653 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 5 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE ARBORESCENS FLOWER (UNII: U449SE7IPV) ASCORBIC ACID (UNII: PQ6CK8PD0R) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) MATRICARIA CHAMOMILLA LEAF (UNII: 6I9LN466F0) CHOLECALCIFEROL (UNII: 1C6V77QF41) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) CLOVE OIL (UNII: 578389D6D0) PEPPERMINT OIL (UNII: AV092KU4JH) OCTYLDODECANOL (UNII: 461N1O614Y) OLIVE OIL (UNII: 6UYK2W1W1E) PEG-8 DIMETHICONE (UNII: GIA7T764OD) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ALCOHOL (UNII: 3K9958V90M) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA (UNII: 208G222332) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CORN OIL (UNII: 8470G57WFM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46122-653-34 85 g in 1 PACKAGE; Type 0: Not a Combination Product 01/18/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/18/2021 Labeler - Amerisource Bergen LLC (007914906) Establishment Name Address ID/FEI Business Operations Inspec Solutions LLC 081030372 manufacture(46122-653)