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Otoflam

BioActive Nutritional, Inc.
Apotheca Company

Otoflam HP




FULL PRESCRIBING INFORMATION

Active ingredient

ACTIVE INGREDIENTS:  Belladonna 30X, Conium maculatum 30X, Dulcamara 30X, Hepar sulphuris calcareum 30X, Kali bichromicum 30X, Mercurius solubilis 30X, Pulsatilla 30X, Silicea 30X, Chamomilla 30C.

Purpose

INDICATIONS:  For temporary relief of symptoms due to inflammation of the ear.

WARNINGS:  If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

DIRECTIONS:  10 drops orally, 3 times a day.  Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS:  Demineralized water, 25% Ethanol.

KEEP OUT OF REACH OF CHILDREN.  In case of overdose, get medical help or contact a Poison Control Center right away.

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd,

Melbourne, FL 32935


Uses

INDICATIONS:  For temporary relief of symptoms due to inflammation of the ear.

BioActive Homeopathic

OTOFLAM HP

1 FL OZ (30 ml)

Otoflam

Otoflam

Belladonna, Conium maculatum, Dulcamara, Hepar sulphuris calcareum, Kali bichromicum, Mercurius solubilis, Pulsatilla, Silicea, Chamonilla, LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:43857-0034
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ATROPA BELLADONNA ATROPA BELLADONNA 30 [hp_X]
Conium Maculatum Flowering Top CONIUM MACULATUM FLOWERING TOP 30 [hp_X]
Solanum Dulcamara Top Solanum Dulcamara Top 30 [hp_X]
CALCIUM SULFIDE CALCIUM CATION 30 [hp_X]
POTASSIUM DICHROMATE DICHROMATE ION 30 [hp_X]
MERCURIUS SOLUBILIS MERCURIUS SOLUBILIS 30 [hp_X]
PULSATILLA VULGARIS PULSATILLA VULGARIS 30 [hp_X]
SILICON DIOXIDE 30 [hp_X]
Matricaria Recutita MATRICARIA RECUTITA 30 [hp_C]

Inactive Ingredients

Ingredient Name Strength
ALCOHOL
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:43857-0034-1 30 in 1 BOTTLE, DROPPER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2012-07-13


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Be sure to consult your doctor before taking any medication!
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