Monistat Care Itch Relief Spray

Manufacturer
Insight Pharmaceuticals LLC
Effective date
2024-10-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:41:35

Label at a glance#

ProductMonistat Care Instant Itch Relief
Active ingredientBENZOCAINE
Label structure10 sections

Indications and uses

Temporary relief of pain and itching

Dosage and administration

shake can well,  hold 8" to 12" from affected area; spray liberally. adults and children 1 2 years and older:  apply to affected area not more than 3 to 4 times daily children under 1 2 years:  consult a physician

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Monistat Care – Benzocaine 20% / Topical analgesic

PDP

Monistat Care

20 % Benzocaine / Topical analgesic

Instant Itch Relief Spray

NET WT. 2 OZ (57 g)

Drug Facts

Active ingredient 

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Purpose  

OTC - PURPOSE SECTION

Topical analgesic

Uses 

INDICATIONS & USAGE SECTION

Temporary relief of pain and itching

Warnings

WARNINGS SECTION

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

OTC - WHEN USING SECTION

avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY INFORMATION

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

Inactive ingredients 

INACTIVE INGREDIENT SECTION

Polyethylene glycol 300 
Propellant: Isobutane, normal butane, propane

Questions? 

OTC - QUESTIONS SECTION

Call toll free 1-877-666-4782

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL INTENSE ITCH RELIEF MONISTAT Care 20% Benzocaine/ Tropical Analgesic MAXIMUM STRENGTH INSTANT Itch Relief SPRAY Net WT.2 OZ(57g)PRINCIPAL DISPLAY PANEL INTENSE ITCH RELIEF MONISTAT Care 20% Benzocaine/ Tropical Analgesic MAXIMUM STRENGTH INSTANT Itch Relief SPRAY Net WT.2 OZ(57g)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
360349benzocaine 20 % Topical SprayPSN2
1991422Monistat Care Instant Itch Relief 20 % Topical SprayPSN2
1991422benzocaine 200 MG/ML Topical Spray [Monistat Care]SBD2
360349benzocaine 200 MG/ML Topical SpraySCD2
360349benzocaine 20 % Topical SpraySY2
1991422Monistat Care 20 % Topical SpraySY2
1991422Monistat Care 200 MG/ML Topical SpraySY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-050-01Monistat Care Instant Itch Relief57 g in 1 CANSPRAY572

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-050MONISTAT CARE INSTANT ITCH RELIEF (BENZOCAINE) SPRAY [INSIGHT PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 1 package rows20241211_4e9dc791-419f-4c79-aed4-760f8c17a5dd.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63736-05063736-050-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOCAINEU3RSY48JW5ACTIB
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Monistat Care Instant Itch ReliefBENZOCAINEInsight Pharmaceuticals LLC4e9dc791-419f-4c79-aed4-760f8c17a5dd2024-10-25WarningsExact identifier
ndc (package): 63736-050-01
ndc (product): 63736-050
ndc11 (package): 63736005001
spl id: 24484604-8fe8-4781-84b7-2c0ab32800cc
spl set id: 4e9dc791-419f-4c79-aed4-760f8c17a5dd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.