HYLANDS NATURALS EARACHE DROPS- belladonna leaf,calcium carbonate,chamomile,lycopodium clavatum spore,anemone patens whole,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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Hyland's Naturals Earache Drops

Drug Facts

Active ingredientsPurpose*
Belladonna 30C HPUS (less than 0.000000000001% Alkaloids, calculated)ear pain
Calcarea Carbonica 30C HPUSear pain, sensitivity to cold
Chamomilla 30C HPUSear pain, sensitivity to
drafts, plugged ears
Lycopodium 30C HPUSear pain
Pulsatilla 30C HPUSear itching
Sulphur 30C HPUSear pain with burning,
sensitivity to water

HPUS" is the Homeopathic Pharmacopoeia of the
United States.

Uses*

Temporarily relieves:
■ common pain or itching from swimmer’s ear
■ clogged ears
■ ear pain or itching from other earaches,
after diagnosis by a physician

Warnings

Keep away from eyes.

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

Stop use and ask a doctor if:
■ symptoms persist for more than 48 hours or worsen.
■ any discharge from ear is present.
■ symptoms are accompanied by a fever.

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

Drug Facts (continued)

Directions

Adults and children ages
4 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 per day.
■ Use as directed.
■ Do not refrigerate.
■ Shake well before using.

Inactive ingredients

Citric Acid, Glycerine, Purified Water.

Questions?

www.hylands.com
or care@hylands.com

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

DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

Temporarily relieves: common pain or itching from swimmer’s ear, clogged ears, ear pain or itching from other earaches, after diagnosis by a physician

Principal Display Panel

Hyland's

Earache Drops 0.33 FL. OZ. (10 mL)

Earache Drops Label

Earache Drops Carton

HYLANDS NATURALS EARACHE DROPS 
belladonna leaf,calcium carbonate,chamomile,lycopodium clavatum spore,anemone patens whole,sulfur liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-4124
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE30 [hp_C]  in 1 mL
BELLADONNA LEAF (UNII: 6GZW20TIOI) (BELLADONNA LEAF - UNII:6GZW20TIOI) BELLADONNA LEAF30 [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
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-4124-11 in 1 CARTON07/27/2023
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 homeopathic07/27/2023
Labeler - Hyland's Inc. (008316655)
Establishment
NameAddressID/FEIBusiness Operations
Hyland's Inc.008316655manufacture(54973-4124) , pack(54973-4124) , label(54973-4124)

Revised: 10/2024
Document Id: 253ddf65-dafe-1ec7-e063-6294a90ac074
Set id: 017ed754-9fe8-2cb5-e063-6294a90ab2f6
Version: 2
Effective Time: 20241024
 
Hyland's Inc.