MONISTAT CARE INSTANT ITCH RELIEF- benzocaine spray

Monistat Care Instant Itch Relief by

Drug Labeling and Warnings

Monistat Care Instant Itch Relief by is a Otc medication manufactured, distributed, or labeled by Insight Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 

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)

INGREDIENTS AND APPEARANCE

MONISTAT CARE INSTANT ITCH RELIEF 
benzocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63736-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	11.4 g  in 57 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63736-050-01	57 g in 1 CAN; Type 0: Not a Combination Product	10/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	10/01/2017

Labeler - Insight Pharmaceuticals LLC (055665422)