OTIDOLO- atropa bella-donna flowering top, phytolacca americana root, anemone pulsatilla, matricaria recutita flowering top, echinacea angustifolia, and plantago major leaf solution/ drops 
PEKANA Naturheilmittel GmbH

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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OTIDOLO™

Ingredients:
Atropa belladonna2X
Phytolacca americana1X
Pulsatilla vulgaris2X
Chamomilla recutita27.00 mg/ml
Echinacea angustifolia9.00 mg/ml
Plantago major
Anhydrous glycerin		9.00 mg/ml

Contains 16% alcohol by volume.

Indications

Supports the relief of earaches and ear inflammation. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.

Dosage

Unless otherwise prescribed, adults take 1 drop dripped into ear canal, 3 times per day. For pediatric dosages, consult your practitioner.

Warning

If symptoms persist, contact a licensed practitioner. If you have known sensitivity to any of the ingredients, please consult your licensed practitioner before use. If you are pregnant or nursing a baby, seek the advice of a health care professional before use.

Keep out of the reach of children.

Protect from light and heat.

Tamper Evident

Do not use this product if tamper evident strip is broken or removed from base of cap.

To report adverse events, contact BioResource at 321B Blodgett Street, Cotati, CA 94931

Manufactured by:
PEKANA® GmbH
D-88353 Kisslegg

Distributed by:
BioResource Inc.
Cotati, CA 94931

PRINCIPAL DISPLAY PANEL - 10 ml Bottle Box

OTIDOLO™
Ear Drops

Homeopathic
Medicine

Supports the relief
of earaches and ear
inflammation

0.34 FL OZ
(10 ml)

PEKANA®

PRINCIPAL DISPLAY PANEL - 10 ml Bottle Box
OTIDOLO 
atropa bella-donna flowering top, phytolacca americana root, anemone pulsatilla, matricaria recutita flowering top, echinacea angustifolia, and plantago major leaf solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59469-151
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Atropa bella-donna Flowering Top (UNII: B26WXN5GZJ) (Atropa bella-donna Flowering Top - UNII:B26WXN5GZJ) Atropa bella-donna Flowering Top2 [hp_X]  in 10 mL
Phytolacca americana Root (UNII: 11E6VI8VEG) (Phytolacca Americana Root - UNII:11E6VI8VEG) Phytolacca americana Root1 [hp_X]  in 10 mL
Anemone Pulsatilla (UNII: I76KB35JEV) (Anemone Pulsatilla - UNII:I76KB35JEV) Anemone Pulsatilla2 [hp_X]  in 10 mL
MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02) (MATRICARIA CHAMOMILLA FLOWERING TOP - UNII:3VNC7T6Z02) MATRICARIA CHAMOMILLA FLOWERING TOP270 mg  in 10 mL
Echinacea angustifolia (UNII: VB06AV5US8) (Echinacea angustifolia - UNII:VB06AV5US8) Echinacea angustifolia90 mg  in 10 mL
Plantago major Leaf (UNII: 7DC28K241X) (Plantago major Leaf - UNII:7DC28K241X) Plantago major Leaf90 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Water (UNII: 059QF0KO0R)  
Alcohol (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59469-151-051 in 1 BOX04/12/200803/23/2018
110 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED HOMEOPATHIC04/12/200803/23/2018
Labeler - PEKANA Naturheilmittel GmbH (320344542)
Establishment
NameAddressID/FEIBusiness Operations
PEKANA Naturheilmittel GmbH320344542MANUFACTURE(59469-151)

Revised: 3/2018
Document Id: 15e744a0-afc7-4d26-8a38-f93e61c45bc2
Set id: fc3e286e-ce54-4b54-8ba7-4784e2abd9cc
Version: 3
Effective Time: 20180319
 
PEKANA Naturheilmittel GmbH