Label: EARACHE (belladonna, calcarea carbonica, chamomilla, lycopodium clavatum, pulsatilla- vulgaris, sulphur liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 59779-568-15 - Packager: CVS Pharmacy
- 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 April 29, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
ACTIVE INGREDIENTS:
Belladonna 30C HPUS.........................Temperature above normal
Calcarea Carbonica 30C HPUS.............Burning Ear
Chamomilla 30C HPUS.......................Sleeplessness and irritability
Lycopodium Clavatum 30C HPUS.......Ear discomfort
Pulsatilla (Vulgaris) 30C HPUS............Ear itching, discomfort at night
Sulphur 30C HPUS............................Throbbing ear
The letter HPUS indicate that the components of this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
-
USES*:
•For use in the ears only. According to homeopathic indications these ingredients temporarily relieve the symptoms of temperature above normal, discomfort, throbbing, and sleeplessness with earaches after diagnosis by a physician. Relieves common discomfort and itching of "swimmer's ear". *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.
-
WARNINGS:
USE ONLY AFTER DIAGNOSIS BY A PHYSICIAN AND UNDER THE SUPERVISION OF A PHYSICIAN.
Keep away from the eyes.
• This product is intended to complement, not replace standard medical treatment. • Initial worsening of the symptoms may occur.
• A physician should always be consulted to rule out serious causes.
• If pregnant or breast-feeding, ask a health professional before use.
• Keep out of the reach of children.
• If swallowed, get medical help or contact a Poison Control Center right away.
Do not use
• If you have ear drainage, irritation, discharge or rash in the ear, consult a physician.
• With ear tubes, damaged ear drums or after surgery.
• If drops become cloudy.
Stop use and ask a doctor if
• Symptoms worsen or continue for more than 48 hours.
• There is discharge from the ear.
• A fever greater than 102°F is present.
-
OTHER SAFETY INFORMATION:
Active ingredients are micro-diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects.
• Store at 15°C-30°C (59°F-86°F).
• Protect from light and excessive moisture.
†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
- DO NOT USE:
- KEEP OUT OF REACH OF CHILDREN:
-
DIRECTIONS:
Suitable for adults and children over the age of 2.
• For use in the ears only.
• Remove any hearing aids before using this product.
• Use 3 to 5 drops twice per day or as needed.
• Warm contents to body temperature by holding bottle in your hands.
• Tilt your head to the side and let solution drip into the ear. Never put the tip into the ear canal.
• Keep drops in your ear by tilting your head for 1-2 minutes or gently place cotton in the ear to keep drops in.
-
INDICATIONS:
•For use in the ears only. According to homeopathic indications these ingredients temporarily relieve the symptoms of temperature above normal, discomfort, throbbing, and sleeplessness with earaches after diagnosis by a physician. Relieves common discomfort and itching of "swimmer's ear". *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
-
INGREDIENTS AND APPEARANCE
EARACHE
belladonna, calcarea carbonica, chamomilla, lycopodium clavatum, pulsatilla (vulgaris), sulphur liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-568 Route of Administration AURICULAR (OTIC) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 30 [hp_C] in 1 mL OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 30 [hp_C] in 1 mL MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 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 PULSATILLA VULGARIS (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS 30 [hp_C] in 1 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 30 [hp_C] in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-568-15 10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 04/22/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/22/2016 Labeler - CVS Pharmacy (062312574) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(59779-568) , api manufacture(59779-568) , label(59779-568) , pack(59779-568)
