CLEARLIFE- onion, galphimia glauca flowering top, histamine dihydrochloride, luffa operculata fruit and sulfur spray

Clearlife by

Drug Labeling and Warnings

Clearlife by is a Homeopathic medication manufactured, distributed, or labeled by MediNatura. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Active Ingredients: Each 20ml contains: *Allium cepa 4X 5%, *Allium cepa 12X 5%, *Allium cepa 30X 5%, *Galphimia glauca 3X 1.1 %, *Galphimia glauca 12X 10%,*Galphimia glauca 30X 10%, Histaminum hydrochloricum 12X 5%, Histaminum hydrochloricum 30X 5%, Histaminum hydrochloricum 200X 5%, *Luffa operculata 3X, *Luffa operculata 12X 10%, *Luffa operculata 30X 10%, *Sulphur 11X 0.55%, *Sulphur 30X 0.55%, *Sulphur 200X 0.55%.

*Natural Ingredients.

PURPOSE

Relieves:

• Runny Nose
• Sneezing
• Congestion

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS AND USAGE

For the temporary relief of minor allergy symptoms:

• Runny nose and sneezing
• Nasal congestion

WARNINGS

Ask a doctor before use if you have asthma. In rare cases broncho-spasm may occur in asthmatic patients. Temporary burning, stinging, sneezing or increased nasal discharge may occur. If pregnant or breast-feeding, ask a healthcare professional before use. Keep out of reach of children. The use of this dispenser by more than one person may spread infection. If symptoms persist or worsen, a healthcare professional should be consulted. Do not use if known sensitivity to ClearLife™ or any of its ingredients exists.

DOSAGE AND ADMINISTARTION

Directions:

Adults and children 12 years and older: During an allergy attack: 2 sprays into each nostril every 2-4 hours.  For daily protection:2 sprays into each nostril daily. Do not exceed 24 sprays in 24 hours.

Adults and children 12 years and older: 2 sprays into each nostril every 4 to 6 hours.

Children 4 to 11 years:During an allergy attack:1 spray into each nostril every 4 to 6 hours.

For children under 4 years, consult your healthcare provider.

Children 4 to 11 years: 1 spray into each nostril every 2-4 hours until symptoms lessen, then continue with standard dosage. Do not exceed 12 sprays into each nostril per 24 hours.

For children under 4 years, consult your healthcareprofessional.

INACTIVE INGREDIENTS

Benzalkonium chloride, Disodium phosphate dihydrate, Isotonic sodiumchloride solution, Sodium dihydrogen phosphate dihydrate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLEARLIFE  
onion, galphimia glauca flowering top, histamine dihydrochloride, luffa operculata fruit and sulfur spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62795-4002
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	4 [hp_X]  in 20 mL
GALPHIMIA GLAUCA FLOWERING TOP (UNII: 93PH5Q8M7E) (GALPHIMIA GLAUCA FLOWERING TOP - UNII:93PH5Q8M7E)	GALPHIMIA GLAUCA FLOWERING TOP	3 [hp_X]  in 20 mL
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	12 [hp_X]  in 20 mL
LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU)	LUFFA OPERCULATA FRUIT	3 [hp_X]  in 20 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	11 [hp_X]  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62795-4002-9	1 in 1 CARTON	04/11/2013
1		20 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		04/11/2013

Labeler - MediNatura (079324099)

Establishment
Name	Address	ID/FEI	Business Operations
MediNatura		102783016	manufacture(62795-4002)