Label: CHIGGEREX 2X MEDICATED- benzocaine 10.0% ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 64048-1111-1 - Packager: Product Quest Mfg
- 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 October 4, 2017
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Uses
- WarningsFor external use only
- KEEP OUT OF REACH OF CHILDREN
- Directions
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Inactive ingredients
Water
PEG-2 Stearate SE, PEG-2 Stearate
Olea Europaea (Olive) Fruit Extract
Aloe Barbadensis Leaf Juice
Methylparaben
Diazolidinyl Urea
Mentha Piperita (Peppermint) Oil
Eugenia Caryophyllus (Clove) Flower Oil
Propylparaben
Chamomilla Recutita (Matricaria) Flower Extract
PEG-8 Dimethicone, Zea Mays (Corn) Oil, Propylene Glycol, Octyldodecanol, Tocopheryl
Acetate, Ascorbic Acid, Retinyl Palmitate, Pyridoxine HCl, Cholecalciferol, Sodium
Propoxyhydroxypropyl Thiosulfate Silica
Fragrance
Disodium EDTA
Camphor - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHIGGEREX 2X MEDICATED
benzocaine 10.0% ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64048-1111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) Benzocaine 10 g in 100 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) PEG-2 STEARATE (UNII: 94YQ11Y95F) BLACK OLIVE (UNII: 2M6QWV94OC) ALOE VERA LEAF (UNII: ZY81Z83H0X) Methylparaben (UNII: A2I8C7HI9T) Diazolidinyl Urea (UNII: H5RIZ3MPW4) PEPPERMINT OIL (UNII: AV092KU4JH) CLOVE OIL (UNII: 578389D6D0) Propylparaben (UNII: Z8IX2SC1OH) CHAMOMILE (UNII: FGL3685T2X) PEG-8 DIMETHICONE (UNII: GIA7T764OD) CORN OIL (UNII: 8470G57WFM) Propylene Glycol (UNII: 6DC9Q167V3) Octyldodecanol (UNII: 461N1O614Y) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Ascorbic Acid (UNII: PQ6CK8PD0R) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) Cholecalciferol (UNII: 1C6V77QF41) SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA (UNII: 208G222332) EDETATE DISODIUM (UNII: 7FLD91C86K) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64048-1111-1 50 g in 1 TUBE; Type 0: Not a Combination Product 02/18/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/18/2013 Labeler - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(64048-1111) , label(64048-1111)