COMBINATION REMEDY 12 - IRRITATED WATERY EYE- belladonna, euphrasia officinalis, ferrum phosphoricum, phosphorus, pulsatilla, solution/ drops

Combination Remedy 12 - Irritated Watery Eye by

Drug Labeling and Warnings

Combination Remedy 12 - Irritated Watery Eye by is a Homeopathic medication manufactured, distributed, or labeled by Warsan Homoeopathic Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

Stop use and ask doctor if symptoms worsen or persist longer than 7 days.

If pregnant or breast-feeding, ask health professional before use.

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

ACTIVE INGREDIENT

Belladonna 2X

Euphrasia Officinalis 6X

Ferrum Phosphoricum 6X

Phosphorus 6X

Pulsatilla 30X

Ruta Graveolens 6X

Staphysagria 30X

PURPOSE

Temporary relief from discomfort, swelling, itching of eye or eyelid, gritty feeling in eyes, crust on eyelid, irritated eyes, fatigued eyes from reading, driving, computer use.

INACTIVE INGREDIENT

Purified Water

Alcohol

DOSAGE & ADMINISTRATION

Adults and children 12 years and older: Take 10-15 drops in half cup of water 3 times a day.

Children 2 years to under 12 years: Take 8-10 drops in half cup of water of 3 times a day.

Children under 2 years: Consult doctor prior to use.

INDICATIONS & USAGE

Temporary relief from discomfort, swelling, itching of eye or eyelid, gritty feeling in eyes, crust on eyelid, irritated eyes, fatigued eyes from reading, driving, computer use.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COMBINATION REMEDY 12 - IRRITATED WATERY EYE 
belladonna, euphrasia officinalis, ferrum phosphoricum, phosphorus, pulsatilla, solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69008-4012
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERRUM PHOSPHORICUM - UNII:91GQH8I5F7)	FERRUM PHOSPHORICUM	6 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	6 [hp_X]  in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	2 [hp_X]  in 1 mL
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	6 [hp_X]  in 1 mL
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV)	DELPHINIUM STAPHISAGRIA SEED	30 [hp_X]  in 1 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	6 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	30 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69008-4012-1	20 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	11/16/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/15/2017

Labeler - Warsan Homoeopathic Laboratories (645579772)

Registrant - Warsan Homoeopathic Laboratories (645579772)

Establishment
Name	Address	ID/FEI	Business Operations
Warsan Homoeopathic Laboratories		645579772	manufacture(69008-4012) , pack(69008-4012) , label(69008-4012)