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NDC 63736-0050-01 Monistat Care Instant Itch Relief 11.4 g/57g Details

Monistat Care Instant Itch Relief 11.4 g/57g

Monistat Care Instant Itch Relief is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Insight Pharmaceuticals LLC. The primary component is BENZOCAINE.

Product Information

NDC	63736-0050
Product ID	63736-050_9b8a641e-489e-497f-a3f0-154d8d836c59
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Monistat Care Instant Itch Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzocaine
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	11.4
Active Ingredient Units	g/57g
Substance Name	BENZOCAINE
Labeler Name	Insight Pharmaceuticals LLC
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63736-0050-01 (63736005001)

Pricing Information	N/A
NDC Package Code	63736-050-01
Billing NDC	63736005001
Package	57 g in 1 CAN (63736-050-01)
Marketing Start Date	2017-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4e9dc791-419f-4c79-aed4-760f8c17a5dd Details

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

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

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

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

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

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