KIDS RELIEF EAR RELIEF- ferrum phosphoricum, capsicum annuum, pyrogenium, arsenicum album, belladonna liquid 
HOMEOLAB USA INC

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.

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DRUGS FACTS

Active ingredients HPUS*

Ferrum phosphoricum (Ferrosoferric phosphate) 30X

Capsicum annuum (Cayenne pepper) 30X

Pyrogenium (Pyrogen) 30X

Arsenicum album (Arsenous oxide) 30X

Belladonna (Deadly nightshade) 30X

Purpose

Ferrum phosphoricum (Ferrosoferric phosphate) 30X............................................sensitivity to touch

Capsicum annuum (Cayenne pepper) 30X...........................................................sensitivity to touch

Pyrogenium (Pyrogen) 30X................................................................................coldness and chilliness

Arsenicum album (Arsenous oxide) 30X...............................................................burning sensation of the ear

Belladonna (Deadly nightshade) 30X...................................................................fullness of the ear, night time calmative

The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.

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.

RETAIN CARTON FOR COMPLETE INSTRUCTIONS

Warnings


Do not use if imprinted shrink seal neckband is broken or missing.

Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist for more than 2 days.

Keep out of reach of children. 

Directions

Do not use more than directed.

Do not take with food.

Take 0.75 mL orally.

Repeat every 8 hours and reduce with improvement or as directed by a healthcare professional.

Infants and children 0 to 9 years of age: 0.75 mL

Other information

Store at room temperature.

Inactive ingredients

Purified water, sorbitol, grape and raspberry flavor, sodium benzoate, potassium sorbate, citric acid.

CARTON

image of carton

KIDS RELIEF EAR RELIEF 
ferrum phosphoricum, capsicum annuum, pyrogenium, arsenicum album, belladonna liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-9163
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM30 [hp_X]  in 25 mL
CAPSICUM ANNUUM WHOLE (UNII: 7FKZ3QQQ1F) (CAPSICUM ANNUUM WHOLE - UNII:7FKZ3QQQ1F) CAPSICUM ANNUUM WHOLE30 [hp_X]  in 25 mL
RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU) RANCID BEEF30 [hp_X]  in 25 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC CATION (3+)30 [hp_X]  in 25 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA30 [hp_X]  in 25 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE, RASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60512-9163-81 in 1 CARTON
125 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/15/2014
Labeler - HOMEOLAB USA INC (202032533)
Establishment
NameAddressID/FEIBusiness Operations
HOMEOLAB USA INC202032533manufacture(60512-9163)

Revised: 1/2014
Document Id: 45a6f39c-d835-4f00-a5f6-1982f143f7e1
Set id: 70ef084a-b2e8-4afa-90e3-c921a78afd3f
Version: 1
Effective Time: 20140115
 
HOMEOLAB USA INC