Monistat Care Instant Itch Relief Spray
FDA Label NDC 63736-050

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 Care Instant Itch Relief (NDC 63736-050). 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, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Benzocaine 20%

Purpose

Topical analgesic

Uses

Temporary relief of pain and itching

Warnings

For external use only

Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

Contents under pressure. Do not puncture or incinerate. Flammable mixture; do not use near fire or flame, or expose to heat or temperatures above 49°C (120°F). Use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

When Using This Product

avoid contact with the eyes

Stop Use And Ask A Doctor If

  • condition worsens, or symptoms persists for more than 7 days
  • symptoms 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

  • shake can well, hold 8" to 12" from affected area; spray liberally.
  • adults and children 12 years and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years: consult a physician

Other Information

Store at room temperature 15°– 25°C (59°– 77°F).

Inactive Ingredients

Polyethylene glycol 300 
Propellant: Isobutane, normal butane, propane

Questions?

Call toll free 1-877-666-4782

Principal Display Panel

MONISTAT
Care
20% Benzocaine/ Tropical Analgesic
MAXIMUM STRENGTH
INSTANT
Itch Relief
SPRAY
Net WT.2 OZ(57g)

Principal Display Panelintenseitch Reliefmonistatcare20% Benzocaine/ Tropical Analgesicmaximum Strengthinstantitch Reliefspraynet Wt.2 Oz(57g) (Monistat Care Itch Relief Spray 01)

Principal Display Panelintenseitch Reliefmonistatcare20% Benzocaine/ Tropical Analgesicmaximum Strengthinstantitch Reliefspraynet Wt.2 Oz(57g) (Monistat Care Itch Relief Spray 01)

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