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

Hylands Naturals Earache Drops by

Drug Labeling and Warnings

Hylands Naturals Earache Drops by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

OTHER SAFETY INFORMATION

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

PURPOSE

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)

INGREDIENTS AND APPEARANCE

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)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/27/2023

Labeler - Hyland's Inc. (008316655)

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