Label: AURO HOMEOPATHIC EAR RELIEF DROPS- atropa belladonna, oyster shell calcium carbonate, crude, capsicum, matricaria recutita, potassium dichromate, plantago major, and verbascum thapsus liquid
- NDC Code(s): 63736-326-26
- Packager: Insight Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated July 2, 2020
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- SPL UNCLASSIFIED SECTION
- Active ingredients (in each drop)
- Purpose
- Uses
- Warnings
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Directions
for adults and children over 6 months of age tilt head sideways and apply 3-4 drops into the affected ear up to 4 times daily. Tip of dropper should not enter ear canal. To keep drops in, tilt ear upward after application or gently place cotton in the ear. children under 6 months of age consult a doctor - Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
AURO HOMEOPATHIC EAR RELIEF DROPS
atropa belladonna, oyster shell calcium carbonate, crude, capsicum, matricaria recutita, potassium dichromate, plantago major, and verbascum thapsus liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-326 Route of Administration AURICULAR (OTIC) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna 18 [hp_X] in 0.05 mL Oyster Shell Calcium Carbonate, Crude (UNII: 2E32821G6I) (Oyster Shell Calcium Carbonate, Crude - UNII:2E32821G6I) Oyster Shell Calcium Carbonate, Crude 12 [hp_X] in 0.05 mL Capsicum (UNII: 00UK7646FG) (Capsicum - UNII:00UK7646FG) Capsicum 6 [hp_X] in 0.05 mL Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita 15 [hp_X] in 0.05 mL Potassium Dichromate (UNII: T4423S18FM) (Dichromate Ion - UNII:9LKY4BFN2V) Potassium Dichromate 12 [hp_X] in 0.05 mL Plantago Major (UNII: W2469WNO6U) (Plantago Major - UNII:W2469WNO6U) Plantago Major 4 [hp_X] in 0.05 mL Verbascum Thapsus (UNII: C9TD27U172) (Verbascum Thapsus - UNII:C9TD27U172) Verbascum Thapsus 4 [hp_X] in 0.05 mL Inactive Ingredients Ingredient Name Strength Chamomile (UNII: FGL3685T2X) Citric Acid Monohydrate (UNII: 2968PHW8QP) Glycerin (UNII: PDC6A3C0OX) Sodium Benzoate (UNII: OJ245FE5EU) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63736-326-26 1 in 1 CARTON 11/15/2013 1 29.6 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 11/15/2013 Labeler - Insight Pharmaceuticals LLC (055665422)