Label: EARACHE DROPS- belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur liquid
- NDC Code(s): 54973-3172-1, 54973-3172-2
- Packager: Hyland's Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated December 12, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Purpose
-
Drug Facts
Active ingredients Purpose Belladonna 30C HPUS
(less than 0.000000000001% Alkaloids, calculated)
minor fever Calcarea Carbonica 30C HPUS
throbbing ear painChamomilla 30C HPUS
occasional sleeplessness and irritabilityLycopodium 30C HPUS ear pain Pulsatilla 30C HPUS
ear itching, pain worse at nightSulphur 30C HPUS ear pain with burning
"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States. - Uses
- Warnings
-
Directions
Adults and children ages 2 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.
- Drug Facts (continued)
- Questions?
- *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
- DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
EARACHE DROPS
belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3172 Route of Administration AURICULAR (OTIC) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BELLADONNA LEAF (UNII: 6GZW20TIOI) (BELLADONNA LEAF - UNII:6GZW20TIOI) BELLADONNA LEAF 30 [hp_C] in 1 mL CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 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 ANEMONE PATENS WHOLE (UNII: 4M1169RWJD) (ANEMONE PATENS WHOLE - UNII:4M1169RWJD) ANEMONE PATENS WHOLE 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:54973-3172-1 1 in 1 CARTON 06/17/2004 1 10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 2 NDC:54973-3172-2 1 in 1 CARTON 06/17/2004 12/28/2021 2 12 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 06/17/2004 Labeler - Hyland's Inc. (008316655) Establishment Name Address ID/FEI Business Operations Hyland's Inc. 008316655 manufacture(54973-3172) , pack(54973-3172) Establishment Name Address ID/FEI Business Operations Lifetech Resources 622559110 manufacture(54973-3172) , pack(54973-3172)