Monistat 3 Combination Pack
FDA Label NDC 54868-4238

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Monistat 3 Combination Pack (NDC 54868-4238). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding uses, warnings, directions, other information, inactive ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Uses

  • treats vaginal yeast infections
  • relieves external itching and irritation due to a vaginal yeast infection

Warnings

For vaginal use only

Directions

  • before using this product read the enclosed consumer information leaflet for complete directions and information
  • adults and children 12 years of age and over:
  • suppositories: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Throw away applicator after use.
  • external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed.
  • children under 12 years of age: ask a doctor

Other Information

  • do not use if printed suppository blister is torn, open or incompletely sealed

  • do not use if seal over tube opening has been punctured or embossed design

    Embossed Design (Monistat 01)

    Embossed Design (Monistat 01)

    is not visible

  • do not purchase if carton is open
  • store at 20°-25°C (68°-77°F)

Inactive Ingredients

suppository: hydrogenated vegetable oil base

external cream: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol

Principal Display Panel

54868-4238-0

MONISTAT® 3
COMBINATION PACK

Miconazole Nitrate Vaginal Suppositories (200mg) and Miconazole Nitrate Vaginal Cream (2%)
Vaginal Antifungal

(Miconazole Nitrate 200 mg per suppository plus 2% external vulvar cream)

CURES MOST VAGINAL YEAST INFECTIONS

AND RELIEVES ASSOCIATED EXTERNAL ITCHING AND IRRITATION

ORTHO

3 Vaginal Suppositories with Disposable
Applicators plus External Cream

Net Wt. 3 Suppositories
0.32 oz (9g) tube

Principal Display Panel (4238)

Principal Display Panel (4238)




Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma     74146

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