FDA Product

Fem pH

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Fem pH

FDA Product Code

0813-0799

Regulatory Information

NDC Product Code

0813-0799

Effective Date

January 18, 2023

FDA Title

Fem pH™ Therapeutic Vaginal Jelly

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

9

Company Information

ManufacturerPharmics, Inc.

DUNS Number

058560996

Active Ingredients

POLYETHYLENE GLYCOL 4500

Code: TVH7653921

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

Quantity: 0.009 g in 1 g

Code: Q40Q9N063P

Class Code: ACTIB

LACTIC ACID

Code: 33X04XA5AT

Class Code: IACT

OXYQUINOLINE SULFATE

Quantity: 0.00025 g in 1 g

Code: 61VUG75Y3P

Class Code: ACTIM

Active Moieties

ACETIC ACID

Code: Q40Q9N063P

OXYQUINOLINE

Code: 5UTX5635HP

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