Label: BITE AND STING RELIEF SIGNATURE CARE- benzocaine 5.00% spray
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Contains inactivated NDC Code(s)
NDC Code(s): 21130-337-03 - Packager: Better Living
- 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 18, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Uses
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WARNINGS
Warnings
For external use only.Flammable: Do not use while smoking or near heat or flame
When using this product • use only as directed • avoid contact with eyesDo not puncture or incenerate. Contents under pressure. Do not store at temperature above 120F
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 REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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Inactive ingredients
Aloe Barbadensis Leaf 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
PEG-8 Dimethicone
Propylene Glycol
Pyridoxine HCl
Retinyl Palmitate
SD Alcohol 40
Silica
Sodium Propoxyhydroxypropyl Thiosulfate Silica
Tocopheryl Acetate
Zea Mays (Corn) Oil - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BITE AND STING RELIEF SIGNATURE CARE
benzocaine 5.00% sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-337 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 VERA LEAF (UNII: ZY81Z83H0X) Ascorbic Acid (UNII: PQ6CK8PD0R) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) CHAMOMILE (UNII: FGL3685T2X) 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:21130-337-03 85 g in 1 CAN; Type 1: Convenience Kit of Co-Package 03/30/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/30/2018 Labeler - Better Living (009137209) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(21130-337) , label(21130-337)
