Drug Facts

Active ingredients	Purpose*
Belladonna 30C HPUS (less than 0.000000000001% Alkaloids, calculated)	ear pain
Calcarea Carbonica 30C HPUS	ear pain, sensitivity to cold
Chamomilla 30C HPUS	ear pain, sensitivity to drafts, plugged ears
Lycopodium 30C HPUS	ear pain
Pulsatilla 30C HPUS	ear itching
Sulphur 30C HPUS	ear 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 Naturals

Earache Drops 0.33 FL. OZ. (10 mL)

carton

label

HYLANDS NATURALS EARACHE DROPS
belladonna leaf,calcium carbonate,chamomile,lycopodium clavatum spore,anemone patens whole,sulfur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54973-4124
Route of Administration	AURICULAR (OTIC)

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:54973-4124-1	1 in 1 CARTON	07/27/2023
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/27/2023

Labeler - Hyland's Inc. (008316655)

Name	Address	ID/FEI	Business Operations
Establishment
Hyland's Inc.		008316655	manufacture(54973-4124) , pack(54973-4124) , label(54973-4124)