EARACHE DROPS- belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur liquid

EARACHE DROPS by

Drug Labeling and Warnings

EARACHE DROPS by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc., Lifetech Resources. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Belladonna 30C HPUS

(less than 0.000000000001% Alkaloids, calculated)

Calcarea Carbonica 30C HPUS

Chamomilla 30C HPUS

Lycopodium 30C HPUS

Pulsatilla 30C HPUS

Sulphur 30C HPUS

"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Purpose

minor fever

throbbing ear pain

occasional sleeplessness and irritability

ear pain

ear itching,pain worse at night

ear pain with burning

Uses

Temporarily relieves the symptoms of: 

• minor fever 
• ear pain or throbbing 
• irritability or occasional sleeplessness associated with earaches after diagnosis by a physician 
• common pain or itching of "swimmer’s ear"

Warnings

Keep away from eyes. Do not take by mouth. Earache drops are only to be used in ears.

As with any drug, ask a doctor before use if pregnant or breast-feeding.

Do not use if you have ear tubes, damaged ear drums or after ear surgery.

Consult a physician if:

• symptoms persist for more than 48 hours or worsen.
• discharge from ear is present.
• symptoms are accompanied by a high fever (over 101°F).

Drug Facts (continued)

Keep this and all medications out of the reach of children. If swallowed, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Directions

• Shake well before using.

Adults and children ages 2 years and over:

Tilt head sideways and apply 3-4 drops into involved ear (Tip of applicator should not enter ear canal).

Keep head tilted for at least 2 minutes to keep drops in ear. Repeat until relieved, up to 4 times daily.

Other information

• Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.
• Store at room temperature.
• Do not refrigerate.

Inactive ingredients

Citric Acid, Glycerine, Purified Water, Sodium Benzoate.

Questions or comments?

(800) 624-9659

SPL UNCLASSIFIED SECTION

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT

ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

NDC: 54973-3172-1
HOMEOPATHIC

Natural
Relief

SINCE 1903
Hyland's®

EARACHE
DROPS

RELIEVES EAR

PAIN FAST*

CALMS & SOOTHES
EARACHES DUE TO:

• COLD & FLU
• ALLERGY
• MINOR FEVER

0.33 FL. OZ.
(10 mL)

*SEE NOTE ON SIDE

PANEL BELOW

DRUG FACTS

INGREDIENTS AND APPEARANCE

EARACHE DROPS 
belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3172
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BELLADONNA LEAF (UNII: 6GZW20TIOI) (BELLADONNA LEAF - UNII:6GZW20TIOI)	BELLADONNA LEAF	30 [hp_C]  in 1 mL
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	30 [hp_C]  in 1 mL
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	30 [hp_C]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	30 [hp_C]  in 1 mL
ANEMONE PATENS WHOLE (UNII: 4M1169RWJD) (ANEMONE PATENS WHOLE - UNII:4M1169RWJD)	ANEMONE PATENS WHOLE	30 [hp_C]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	30 [hp_C]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3172-1	1 in 1 CARTON	06/17/2004
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 54973-3172-2	1 in 1 CARTON	06/17/2004
2		12 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		06/17/2004

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3172) , pack(54973-3172)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources		622559110	manufacture(54973-3172) , pack(54973-3172)