BABY INFANT EARACHE DROPS- belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur liquid 
Hyland's 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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BABY INFANT EARACHE DROPS

■ Temporarily relieves symptoms of earache in children after diagnosis by a physician, including:
■ minor fever ■ ear pain or throbbing
■ irritability ■ occasional sleeplessness
■ common pain or itching of "swimmer’s ear"

Drug Facts

Active ingredientsPurpose

Belladonna 30C HPUS

(less than 0.0000000000001 % Alkaloids, calculated)

fever
Calcarea Carbonica 30C HPUSthrobbing ear pain
Chamomilla 30C HPUSoccasional sleeplessness and irritability
Lycopodium 30C HPUSear pain
Pulsatilla 30C HPUSear itching, pain worse at night
Sulphur 30C HPUSear pain with burning

"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States

Uses

■ Temporarily relieves symptoms of earache in children after diagnosis by a physician, including:
■ minor fever ■ ear pain or throbbing
■ irritability ■ occasional sleeplessness
■ 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 the ears.

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).

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.

Children under
6 months
Consult a physician.
Children 6 months
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.

Drug Facts (continued)

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

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

HOMEOPATHIC

NDC 54973-7516-3

6+

months

NEW

LOOK

BABY

SINCE 1903
Hyland's

Infant
Earache Drops*


Relieves earache due to cold, flu,
allergy and swimmer's ear


NO DYES or PARABENS
NO NUMBING EFFECT


Natural
Relief

0.33 FL.OZ. (10mL)


*SEE NOTE ON SIDE
PANEL BELOW DRUG FACTS

Carton

BABY INFANT EARACHE DROPS 
belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-7516
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BELLADONNA LEAF (UNII: 6GZW20TIOI) (BELLADONNA LEAF - UNII:6GZW20TIOI) BELLADONNA LEAF30 [hp_C]  in 1 mL
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE30 [hp_C]  in 1 mL
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE30 [hp_C]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE30 [hp_C]  in 1 mL
PULSATILLA PATENS WHOLE (UNII: 4M1169RWJD) (PULSATILLA PATENS WHOLE - UNII:4M1169RWJD) PULSATILLA PATENS WHOLE30 [hp_C]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR30 [hp_C]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-7516-31 in 1 CARTON03/16/2004
110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/16/2004
Labeler - Hyland's Inc. (008316655)
Establishment
NameAddressID/FEIBusiness Operations
Hyland's Inc.008316655manufacture(54973-7516) , pack(54973-7516)
Establishment
NameAddressID/FEIBusiness Operations
Lifetech Resources622559110manufacture(54973-7516) , pack(54973-7516)

Revised: 11/2022
Document Id: ee8d0910-e9ad-0692-e053-2a95a90a6d8c
Set id: d3f3c5c8-c723-4665-aa3b-2da62d68d258
Version: 7
Effective Time: 20221128
 
Hyland's Inc.