Monistat Complete Care Chafing Relief
FDA Label NDC 57501-087

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Apex International Mfg., Llc for the product Monistat Complete Care Chafing Relief (NDC 57501-087). 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, use, warnings, do not use on, 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

Dimethicone 1.2%

Purpose

Skin Protectant

Use

  • Temporarily protects and helps relieve chafed, chapped or cracked skin.

Warnings

For external use only.

Do Not Use On

  • deep or puncture wounds
  • animal bites
  • serious burns

When Using This Product

do not get into eyes.

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms last 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

Apply as needed.

Other Information

Store at 20˚-25˚C (68˚-77˚F)

Inactive Ingredients

cyclomethicone, dimethicone, dimethicone/vinyl dimethicone crosspolymer, silica dimethyl silylate, vinyl dimethicone/methicone silsesquioxane crosspolymer 

Questions?

1-877-666-4782 Monistat.com

Principal Display Panel

MONISTAT
Care®
Chafing Relief
Powder Gel®
Dimethicone/Skin Protectant
Dimeticona / Protector Para La Piel
NET WT / PESA NETO 1.5 oz (42g)

Label (Label)

Label (Label)

* Please review the disclaimer below.