DORAMA-NEO- water liquid 
Sato Pharmaceutical Co., Ltd.

----------

Dorama-Neo

Active ingredient    Purified water 98.4%

Purpose    Eyewash

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
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.

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

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

carton

DORAMA-NEO 
water liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-020
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.4 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49873-020-011 in 1 CARTON11/08/1983
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01811/08/1983
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIBusiness Operations
Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-020) , label(49873-020) , pack(49873-020)

Revised: 12/2023
Document Id: 0bde6cb8-4ea3-da1f-e063-6294a90a0fd4
Set id: 9cff868a-728f-46a0-9edf-6761f8adec6b
Version: 7
Effective Time: 20231206
 
Sato Pharmaceutical Co., Ltd.