Label: COMMON COLD- argentum nitricum, argentum iodatum, argentum metallicum, argentum muriaticum, argentum oxydatum, argentum phosphoricum, echinacea, enchinacea purpurea, gelsemium sempervirens, pulsatilla, sabadilla, scilla maritima, senega officinalis gel
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Contains inactivated NDC Code(s)
NDC Code(s): 57955-1221-1 - Packager: King Bio 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 11, 2018
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Active Ingredients
This nasal ge lconains 80% of Arg nit 4X HPUS and 63.5% of equal volumes of each of the remaining HPUS ingredients in 10X, 30X, and 1LM potencies, unless otherwise noted.
Argentum nitricum, Argentum iodatum, Argentum metallicum, Argentum muriaticum, Argentum oxydatum, Argentum phosphoricum, Echinacea, Enchinacea purpurea, Gelsemium sempervirens, Pulsatilla, Sabadilla, Scilla maritima, Senega officinalis
- Inactive Ingredients
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Directions
Adults and children 12 years of age and older(with adult supervision): 1-2 sprays per nostril 3 times a day.
Initially, depress pumountil primed. Place tip of nozzle just past nasal opening (approx 1/8") While inside nasal opening, slightly angle nozzle outward. Pump 1 to 2 times into each nostril. After application, press lightly on on outside of each nostril for about 5 seconds. Sniff deeply. Wipe nozzle clean after use. Under 12 years of age: consult a healthcare professional before using.
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Purpose
Argentum nitricum (30X, 1LM)............congestion, loss of smell, fever
Argentum iodatum.............................hoarseness
Argentum metallicum..........................mucus, stuffy nose, sneezing
Argentum muriaticum.........................headache
Argentum oxydatum...........................nausea, mucus membrane affections
Argentum phosphoricum.....................swelling
Echinacea.........................................raw and sore nostrils
Enchinacea purpurea..........................nasal congestion, fever
Gelsemium sempervirens....................weakness, achiness, fatigue, chills
Pulsatilla...........................................cough, loss of smell, sore nose
Sabadilla...........................................sneezing, sore throat
Scilla maritima...................................runny nose
Senega officinalis................................headache
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Warnings
For nasal use only. Ask a doctor before use if you have had recent nose ulcers or surgery, have had a nose injury that has not healed. When using this product, use of spray by more than one person may spread infection. Clean tip after use temporary discomfort such as minor burning, stinging, sneezing or an increase in nasal discharge may occur. Stop use and ask a doctor, if symptoms persist or worsen. Ifpregnant or breast-feeding, ask a healthcare professional before use.Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away. Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician.
- KEEP OUT OF REACH OF CHILDREN
- Other Information
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Uses
for the temporary relief of symptoms sucha as:
runny nose, congestion, loss of smell, sneezing, coughing, headaches, fever, chills, sore throat, general weakness, achiness, nausea, fatigue
as per various homeopathis materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COMMON COLD
argentum nitricum, argentum iodatum, argentum metallicum, argentum muriaticum, argentum oxydatum, argentum phosphoricum, echinacea, enchinacea purpurea, gelsemium sempervirens, pulsatilla, sabadilla, scilla maritima, senega officinalis gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-1221 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE 30 [hp_X] in 30 mL SILVER IODIDE (UNII: 81M6Z3D1XE) (SILVER IODIDE - UNII:81M6Z3D1XE) SILVER IODIDE 10 [hp_X] in 30 mL SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER 10 [hp_X] in 30 mL SILVER CHLORIDE (UNII: MWB0804EO7) (SILVER CATION - UNII:57N7B0K90A) SILVER CHLORIDE 10 [hp_X] in 30 mL SILVER OXIDE (UNII: 897WUN6G6T) (SILVER OXIDE - UNII:897WUN6G6T) SILVER OXIDE 10 [hp_X] in 30 mL SILVER PHOSPHATE (UNII: ZL6T4Y1XP8) (SILVER OXIDE - UNII:897WUN6G6T) SILVER PHOSPHATE 10 [hp_X] in 30 mL ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED 10 [hp_X] in 30 mL ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA 10 [hp_X] in 30 mL GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 10 [hp_X] in 30 mL ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 10 [hp_X] in 30 mL SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED 10 [hp_X] in 30 mL DRIMIA MARITIMA BULB (UNII: 3629601H5D) (DRIMIA MARITIMA BULB - UNII:3629601H5D) DRIMIA MARITIMA BULB 10 [hp_X] in 30 mL POLYGALA SENEGA ROOT (UNII: M7T6H7D4IF) (POLYGALA SENEGA ROOT - UNII:M7T6H7D4IF) POLYGALA SENEGA ROOT 10 [hp_X] in 30 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYL SALICYLATE (UNII: LAV5U5022Y) WATER (UNII: 059QF0KO0R) EUCALYPTUS OIL (UNII: 2R04ONI662) GLYCERIN (UNII: PDC6A3C0OX) SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG) HYALURONATE SODIUM (UNII: YSE9PPT4TH) STEVIOL (UNII: 4741LYX6RT) XANTHAN GUM (UNII: TTV12P4NEE) GINGER OIL (UNII: SAS9Z1SVUK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-1221-1 1 in 1 CARTON 01/01/2017 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/2017 Labeler - King Bio Inc (617901350) Registrant - King Bio Inc (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc 617901350 manufacture(57955-1221)