LUBRICANT EYE DROPS- sodium hyaluronate solution/ drops 
MFB Global LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Sodium Hyaluronate 1%

Lubricant

For the temporary relief of burning and irritation due to dryness of the eye.

For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.

For use as a protectant against further irritation or to relieve dryness of the eye.

For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

Relieves redness of the eye due to minor eye irritations.

For external use only

if solution changes color or becomes cloudy.

if you have narrow angle glaucoma.

To avoid contamination, do not touch tip of container to any surface. ■ Replace cap after using. ■ Overuse of this product may produce increased redness of the eye. ■ Pupils may become enlarged temporarily.

if ■ you experience eye pain, changes in vision, continued redness or irritation of the eye. ■ the symptom worsens or persists for more than 72 hours.

If swallowed, get medical help of contact a Poison Control Center right away.

Instill 1 or 2 drops in the affected eye(s) as needed up to four times daily.

Keep refrigerated. Store at 4-10℃(39-50℉). ■ Tamper Evident. Do not use if ring around the bottom of bottle cap is broken or missingminor eye irritations.

Polyquaternium 1

Purified Water.

1-646-339-5789

Manufacturer: DrSignal BioTechnology Co., Ltd. (No. 2-1, Ln. 181, Sec. 2, Jiuzong Rd., Neihu Dist., Taipei City 114, Taiwan)
Distributor: MFB Global LLC
(136-17 39th Ave Suite 301, Flushing, NY 11354, USA) Tel: 1-646-339-5789


Made in Taiwan

product information

refer to following image

LUBRICANT EYE DROPS 
sodium hyaluronate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82357-1101
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONATE SODIUM3 g  in 100 mL
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE0.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLIDRONIUM CHLORIDE (UNII: 6716Z5YR3G)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82357-1101-21 in 1 BOX11/05/2021
1NDC:82357-1101-13 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/05/2021
Labeler - MFB Global LLC (118369923)
Registrant - DrSignal BioTechnology Co., Ltd. (656113584)
Establishment
NameAddressID/FEIBusiness Operations
DrSignal BioTechnology Co., Ltd.656113584manufacture(82357-1101)

Revised: 11/2021
Document Id: d03d3be9-d867-2aad-e053-2995a90aec8c
Set id: cfb13935-6e77-73f0-e053-2a95a90ab3c5
Version: 2
Effective Time: 20211107
 
MFB Global LLC