Label: CHIGGEREX- benzocaine cream
- NDC Code(s): 52412-350-50
- Packager: Randob Labs,Ltd.
- 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 8, 2020
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
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Inactive ingredients
Aloe Barbadensis Leaf Juice, Ascorbic Acid, Camphor, Chamomilla Recutita (Matricaria) Flower Extract, Cholecalciferol, Diazolidinyl Urea, Disodium EDTA, Eugenia Caryophyllus (Clove) Flower Oil, Fragrance,Mentha Piperita (Peppermint) Oil, Methylparaben, Octyldodecanol, Olea Europaea (Olive) Fruit Extract, PEG-2 Stearate, PEG-2 Stearate SE, PEG-8 Dimethicone, Propylene Glycol, Propylparaben, Pyridoxine HCl, Retinyl Palmitate, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Tocopheryl Acetate, Water, Zea Mays (Corn) Oil
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 g Jar Label
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INGREDIENTS AND APPEARANCE
CHIGGEREX
benzocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52412-350 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine 0.1 g in 1 g Inactive Ingredients Ingredient Name Strength Ascorbic Acid (UNII: PQ6CK8PD0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAMPHOR, (-)- (UNII: 213N3S8275) CHAMOMILE (UNII: FGL3685T2X) Cholecalciferol (UNII: 1C6V77QF41) Diazolidinyl Urea (UNII: H5RIZ3MPW4) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) CLOVE OIL (UNII: 578389D6D0) PEPPERMINT OIL (UNII: AV092KU4JH) Methylparaben (UNII: A2I8C7HI9T) Octyldodecanol (UNII: 461N1O614Y) BLACK OLIVE (UNII: 2M6QWV94OC) PEG-2 Stearate (UNII: 94YQ11Y95F) PEG-8 Dimethicone (UNII: GIA7T764OD) Propylene Glycol (UNII: 6DC9Q167V3) Propylparaben (UNII: Z8IX2SC1OH) PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Sodium Propoxyhydroxypropyl Thiosulfate Silica (UNII: 208G222332) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) Water (UNII: 059QF0KO0R) CORN OIL (UNII: 8470G57WFM) Product Characteristics Color YELLOW (Off-White to Yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52412-350-50 50 g in 1 JAR; Type 0: Not a Combination Product 02/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/01/2020 Labeler - Randob Labs,Ltd. (061995007)