EARACHE DROPS- atropa belladonna, oyster shell calcium carbonate, crude, matricaria recutita, lycopodium clavatum spore, pulsatilla vulgaris, and sulfur liquid

EARACHE DROPS by

Drug Labeling and Warnings

EARACHE DROPS by is a Homeopathic medication manufactured, distributed, or labeled by Wal-Mart Stores, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Belladonna 30C HPUS (less than 0.0000000000001% Alkaloids)	Ear pain
Calcarea Carbonica 30C HPUS	Ear pain
Chamomilla 30C HPUS	Ear ache
Lycopodium 30C HPUS	Ear pain
Pulsatilla 30C HPUS	Ear itching
Sulphur 30C HPUS	Ear itching

Uses

Temporarily relieves the symptoms of pain, aches and itching associated with earaches after diagnosis by a physician.

Warnings

Keep away from eyes. Do not take by mouth. Earache drops are only to be used in the ears. Tip of applicator should not enter ear canal.

As with any drug, ask a doctor before use if pregnant or nursing.

Consult a physician if

• symptoms persist for more than 48 hours
• discharge from ear is present

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

Do not use if imprinted tamper band is broken or missing.

In case of emergency contact a medical professional or Poison Control Center immediately. Wal-Mart may also be contacted for emergency information about our products 24 hours a day 7 days a week at 1-888-287-1915.

Directions

Adults and Children 2 years and up: tilt head sideways and apply 3-4 drops into involved ear 4 times daily or as needed. Tilt ear upward for at least 2 minutes after application or gently place cotton in ear to keep drops in.

Inactive Ingredients

Citric Acid, Purified Water, Sodium Benzoate, Vegetable Glycerine

Questions or comments?

1-888-287-1915

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Distributed by:
Wal-Mart Stores, Inc.,
Bentonville, AR 72716

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

NDC: 49035-320-01

equate™

Compare
to Hyland's®
Earache
Drops

Homeopathic

Earache
Drops

Relieves Ear Pain**

0.33 FL OZ (10mL)

INGREDIENTS AND APPEARANCE

EARACHE DROPS 
atropa belladonna, oyster shell calcium carbonate, crude, matricaria recutita, lycopodium clavatum spore, pulsatilla vulgaris, and sulfur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-320
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	30 [hp_C]  in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	30 [hp_C]  in 1 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	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
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	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: 49035-320-01	1 in 1 CARTON
1		10 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		02/25/2015

Labeler - Wal-Mart Stores, Inc (051957769)

Registrant - Standard Homeopathic Company (008316655)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	MANUFACTURE(49035-320) , PACK(49035-320)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources		622559110	MANUFACTURE(49035-320) , PACK(49035-320)