DORAMA-NEO- water liquid

Dorama-Neo by

Drug Labeling and Warnings

Dorama-Neo by is a Otc medication manufactured, distributed, or labeled by Sato Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient    Purified water 98.4%

PURPOSE

Purpose    Eyewash

INDICATIONS & USAGE

Uses  For cleansing the eye to help relieve these symptoms by removing loose foreign material, air pollutants (smog or pollen) or chlorinated water:
■irritation  ■discomfort  ■burning  ■stinging  ■smarting  ■itching

WARNINGS

Warnings
For external use only

Do not use if solution changes color or becomes cloudy

When using this product
■to avoid contamination, do not touch tip of container to any surface
■replace cap after using

Ask a doctor if you experience
■eye pain ■changes in vision
■continued redness or irritation of the eye
■or if the condition worsens or persists

Obtain immediate medical treatment for all open wounds in or near the eyes

Keep our of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions  Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.

INACTIVE INGREDIENT

Inactive ingredients benzalkonium chloride, boric acid, calcium chloride, edetate disodium, potassium chloride, sodium borate, sodium chloride

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DORAMA-NEO 
water liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49873-020
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	98.4 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49873-020-01	1 in 1 CARTON	11/08/1983
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	11/08/1983

Labeler - Sato Pharmaceutical Co., Ltd. (690575642)

Establishment
Name	Address	ID/FEI	Business Operations
Sato Pharmaceutical Co., Ltd.		715699133	manufacture(49873-020) , label(49873-020) , pack(49873-020)