MICROLAX ENEMA- microlax enema enema
MEDIA NETWORKS SYDNEY PTY LIMITED

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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Dosage Form Enema Route of Administration Rectal Visual Identification A colourless, opalescent and viscous preparation.

No Warnings included on Record

glycerol purified water sorbic acid

Permitted Indications No Permitted Indications included on Record Indication Requirements No Indication Requirements included on Record

keep out of reach of children

Single Medicine Product Specific Indications Rectal constipation, faecal incontinence; preparation for X-ray examination and rectoscopy

Active Ingredients

sodium citrate dihydrate 90 mg/mL

sodium lauryl sulfoacetate 9 mg/mL

sorbitol 625 mg/mL

CONTENT OF LABELING Microlax Enema 5mlx12

MICROLAX ENEMA
microlax enema enema

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SORBITOL (UNII: 506T60A25R) (SORBITOL - UNII:506T60A25R)	SORBITOL	625 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)	90 mg in 1 g
SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)	9 mg in 1 g
GLYCEROL FORMAL (UNII: 3L7GR2604E)
WATER (UNII: 059QF0KO0R)
SORBIC ACID (UNII: X045WJ989B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:84177-0020-1	1 g in 1 BOX; Type 0: Not a Combination Product	03/01/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		03/01/2024

Labeler - MEDIA NETWORKS SYDNEY PTY LIMITED (748621327)

Registrant - MEDIA NETWORKS SYDNEY PTY LIMITED (748621327)

Name	Address	ID/FEI	Business Operations
Establishment
MEDIA NETWORKS SYDNEY PTY LIMITED		748621327	manufacture(84177-0020)