Label: KIDS RELIEF EAR RELIEF- ferrum phosphoricum, capsicum annuum, pyrogenium, arsenicum album liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 60512-9214-8 - Packager: HOMEOLAB USA INC
- 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 April 13, 2017
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- Official Label (Printer Friendly)
- Active ingredients HPUS*
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Purpose
Ferrum phosphoricum (Ferrosoferric phosphate) 30X............................................sensitivity to touch
Capsicum annuum (Cayenne pepper) 30X...........................................................sensitivity to touch, fullness of the ear
Pyrogenium (Pyrogen) 30X................................................................................coldness and chilliness
Arsenicum album (Arsenous oxide) 30X...............................................................burning sensation of the ear, night time calmative
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Uses
This oral homeopathic medicine is made from a combination of ingredients traditionnally used to help relieve* the sensation of fullness of the ear, sensitivity to water and drafts, and the annoyance of water-logged ears by helping clear water trapped in the ear.
*These statements have not been reviewed by the Food and Drug Administration. This product is manufactured using traditional homeopathic principles of dilution.
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INGREDIENTS AND APPEARANCE
KIDS RELIEF EAR RELIEF
ferrum phosphoricum, capsicum annuum, pyrogenium, arsenicum album liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60512-9214 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM 30 [hp_X] in 25 mL CAPSICUM ANNUUM WHOLE (UNII: 7FKZ3QQQ1F) (CAPSICUM ANNUUM WHOLE - UNII:7FKZ3QQQ1F) CAPSICUM ANNUUM WHOLE 30 [hp_X] in 25 mL RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU) RANCID BEEF 30 [hp_X] in 25 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC CATION (3+) 30 [hp_X] in 25 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color Score Shape Size Flavor GRAPE, RASPBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60512-9214-8 1 in 1 CARTON 10/26/2016 1 25 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/26/2016 Labeler - HOMEOLAB USA INC (202032533) Establishment Name Address ID/FEI Business Operations HOMEOLAB USA INC 202032533 manufacture(60512-9214)
