Monistat Complete Care Instant Itch Relief Cream
FDA Label NDC 63736-029

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals Llc for the product Monistat Complete Care Instant Itch Relief (NDC 63736-029). 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 active ingredient, purpose, uses, warnings, ask a doctor before use if, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

  • temporarily relieves external genital itching
  • other uses of this product should only be under the advice and supervision of a doctor

Warnings

For external use only

Ask A Doctor Before Use If

you have a vaginal discharge

When Using This Product

  • avoid contact with eyes
  • do not use more than directed
  • do not begin use of any other hydrocortisone product unless you have asked a doctor

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms last for more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children.

If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • adults: apply to affected area not more than 3-4 times daily
  • children under 12 years of age: ask a doctor

Other Information

  • store at 20°-25°C (68°-77°F). Protect from freezing and excessive heat.

Inactive Ingredients

ammonium acryloyldimethyltaurate/VP copolymer, carbomer, ceteareth-6, cetyl alcohol, citric acid, dimethicone, edetate disodium, ethylparaben, glycerin, methylparaben, mineral oil, petrolatum, phenoxyethanol, propylparaben, sodium citrate, sodium hydroxide, stearyl alcohol, VP/eicosene copolymer, water

Questions?

1-877-666-4782 Monistat.com

Dist. by Insight Pharmaceuticals, LLC. 
Tarrytown, NY 10591

A Prestige Brands Company

Principal Display Panel

MONISTAT® 

Care

Itch Relief Cream

Hydrocortisone 1%

NEW WT 1 OZ (28 g)

Principal Display Panelmonistat® Careitch Relief Creamhydrocortisone 1%new Wt 1 Oz (28 G) (Monistat Care Itch Relief Cream 01)

Principal Display Panelmonistat® Careitch Relief Creamhydrocortisone 1%new Wt 1 Oz (28 G) (Monistat Care Itch Relief Cream 01)

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