Ear Discomfort: Homeopathic Product Information

EAR DISCOMFORT- aconitum napellus, bacillus anthracis immunoserum rabbit, arnica montana, baptisia tinctoria root, atropa belladonna, capsicum, matricaria recutita, dysphania ambrosioides whole, euphorbia resinifera resin, lachesis muta venom, magnesium phosphate, dibasic trihydrate, plantago major, anemone pratensis and verbascum thapsus liquid
Liddell Laboratories, 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.

ACTIVE INGREDIENTS:

(in each drop) 7.14% of Aconitum Napellus 200C, Anthracinum 200C, Arnica Montana 200C, Baptisia Tinctoria 3X, Belladonna 200C, Capsicum Annuum 6X, Chamomilla 3X, Chenopodium Anthelminticum 15X, Euphorbium Officinarum 6X, Lachesis Mutus 200C, Magnesia Phosphorica 10X, Plantago Major 3X, Pulsatilla (Pratensis) 30X, Verbascum Thapsus 6X.

INDICATIONS:

May temporarily relieve symptoms of clogging: pressure, sensitivity, or discomfort of the ear.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

Stop use and ask a doctor if symptoms persist for more than 4 days, there is discharge from the ear, or there is a fever.

If pregnant or breast feeding, ask a doctor before use.

Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.

Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.

DIRECTIONS:

Adults and children over 12: Place 15 drops under the tongue up to six times per day until symptoms are relieved.

Children 12 and under: Consult a doctor prior to use.

INDICATIONS:

May temporarily relieve symptoms of clogging: pressure, sensitivity, or discomfort of the ear.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

Organic alcohol 20% v/v, Purified water.

QUESTIONS:

DIST. BY LIDDELL LABORATORIES INC.

WOODBINE, IA 51579

WWW.LIDDELL.NET 1-800-460-7733

PACKAGE LABEL DISPLAY:

ORAL SPRAYS

LIDDELL LABORATORIES

EST. 1994

26 Erd
Ear Discomfort

HOMEOPATHIC

1.0 FL. OZ. (30ml)

Ear Discomfort
(click image for full-size original)
EAR DISCOMFORT
aconitum napellus, anthracinum, arnica montana, baptisia tinctoria, belladonna, capsicum annuum, chamomilla, chenopodium anthelminticum, euphorbium officinarum, lachesis mutus, magnesia phosphorica, plantago major, pulsatilla (pratensis), verbascum thapsus liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50845-0259
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 200 [hp_C] in 1 mL
BACILLUS ANTHRACIS IMMUNOSERUM RABBIT (BACILLUS ANTHRACIS IMMUNOSERUM RABBIT) BACILLUS ANTHRACIS IMMUNOSERUM RABBIT 200 [hp_C] in 1 mL
ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 200 [hp_C] in 1 mL
BAPTISIA TINCTORIA ROOT (BAPTISIA TINCTORIA ROOT) BAPTISIA TINCTORIA ROOT 3 [hp_X] in 1 mL
ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 200 [hp_C] in 1 mL
CAPSICUM (CAPSICUM) CAPSICUM 6 [hp_X] in 1 mL
MATRICARIA RECUTITA (MATRICARIA CHAMOMILLA) MATRICARIA RECUTITA 3 [hp_X] in 1 mL
DYSPHANIA AMBROSIOIDES WHOLE (CHENOPODIUM AMBROSIOIDES) DYSPHANIA AMBROSIOIDES WHOLE 15 [hp_X] in 1 mL
EUPHORBIA RESINIFERA RESIN (EUPHORBIA RESINIFERA RESIN) EUPHORBIA RESINIFERA RESIN 6 [hp_X] in 1 mL
LACHESIS MUTA VENOM (LACHESIS MUTA VENOM) LACHESIS MUTA VENOM 200 [hp_C] in 1 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (MAGNESIUM CATION) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 10 [hp_X] in 1 mL
PLANTAGO MAJOR (PLANTAGO MAJOR) PLANTAGO MAJOR 3 [hp_X] in 1 mL
ANEMONE PRATENSIS (ANEMONE PRATENSIS) ANEMONE PRATENSIS 30 [hp_X] in 1 mL
VERBASCUM THAPSUS (VERBASCUM THAPSUS) VERBASCUM THAPSUS 6 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50845-0259-1 30 mL in 1 BOTTLE, DROPPER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 03/09/2020
Labeler — Liddell Laboratories, Inc. (832264241)
Registrant — Apotheca Company (844330915)
Establishment
Name Address ID/FEI Operations
Apotheca Company 844330915 manufacture (50845-0259), api manufacture (50845-0259), label (50845-0259), pack (50845-0259)

Revised: 03/2020 Liddell Laboratories, Inc.

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