MONISTAT CARE INSTANT ITCH RELIEF- benzocaine spray 
Insight Pharmaceuticals LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Monistat Care Itch Relief Spray

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 

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

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

MONISTAT CARE INSTANT ITCH RELIEF 
benzocaine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE11.4 g  in 57 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-050-0157 g in 1 CAN; Type 0: Not a Combination Product10/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34810/01/2017
Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 12/2017
Document Id: 9b8a641e-489e-497f-a3f0-154d8d836c59
Set id: 4e9dc791-419f-4c79-aed4-760f8c17a5dd
Version: 1
Effective Time: 20171211
 
Insight Pharmaceuticals LLC