SODIUM CHLORIDE

Main information

  • Trade name:
  • SODIUM CHLORIDE- sodium chloride ointment
  • Composition:
  • Sodium Chloride 50 mg in 1 g
  • Administration route:
  • OPHTHALMIC
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SODIUM CHLORIDE- sodium chloride ointment
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Hypertonicity Agent For temporary relief of corneal edema.

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 0363-9050-00
  • Last update:
  • 31-05-2019

Summary of Product characteristics: dosage, interactions, side effects

SODIUM CHLORIDE- sodium chloride ointment

Walgreens

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Sodium Chloride 5%

Purpos e

Hypertonicity Agent

Us e

For temporary relief of corneal edema.

Warnings

do not use this product except under the advice and supervision of a doctor

do not use if cap skirt is dislodged from tube

to avoid contamination, do not touch tip of container to any surface

replace cap after using

may cause temporary burning and irritation upon application into the eye

Stop use and ask a doctor if

you experience eye pain

changes in vision occur

continued redness or irritation of the eye

the condition worsens or persists for more than 72 hours

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

away.

Directions

Apply small amount (one-fourth inch) to the inside of affected eye(s) every 3 to 4 hours, or as directed

by a doctor.

Other Information

store at 20° to 25° C (68° to 77°F) [see USP Controlled Room Temperature].

store away from heat

protect from freezing

keep tightly closed

see crimp for Lot Number and Expiration Date

Retain this carton for future reference

Inactive ingredients

Mineral Oil, Modified Lanolin, Water for Injection and White Petrolatum.

Questions or comments?

1-800-932-5676

Principal Display Panel Text for Container Label:

STERILE Well at

Sodium Chloride Walgreens

Ophthalmic Ointment NDC 0363-9050-00

USP, 5% NET WT 3.5 g (1/8 oz.)

Hypertonicity Eye Ointment

FOR OPHTHALMIC USE ONLY

Principal Display Panel Text for Carton Label:

STERILE Well at

Walgreens NDC 0363-9050-00

WALGREENS PHARMACIST RECOMMENDED≠

Sodium Chloride

Ophthalmic Ointment

USP, 5%

Hypertonicity Eye Ointment

Compare to Muro 128

Ointment active ingredient#

NET WT 3.5 g (1/8 OZ)

SODIUM CHLORIDE

sodium chloride ointment

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 36 3-9 0 50

Route of Administration

OPHTHALMIC

Active Ingredient/Active Moiety

Walgre e ns

Ingredient Name

Basis of Strength

Stre ng th

So dium Chlo ride (UNII: 451W47IQ8 X) (So dium Catio n - UNII:LYR4M0 NH37)

So dium Chlo ride

50 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

Minera l O il (UNII: T5L8 T28 FGP)

La no lin (UNII: 7EV6 5EAW6 H)

Wa ter (UNII: 0 59 QF0 KO0 R)

Petro la tum (UNII: 4T6 H12BN9 U)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 36 3-9 0 50 -0 0

1 in 1 CARTON

0 2/12/20 13

1

3.5 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt349

0 2/12/20 13

Labeler -

Walgreens (008965063)

Registrant -

Akorn, Inc. (062649876)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ako rn,

6 0 39 8 0 319

MANUFACTURE(0 36 3-9 0 50 ) , ANALYSIS(0 36 3-9 0 50 ) , STERILIZE(0 36 3-9 0 50 ) , PACK(0 36 3-9 0 50 )

, LABEL(0 36 3-9 0 50 )

Revised: 12/2017