Label: MONISTAT CARE INSTANT ITCH RELIEF- benzocaine spray
- NDC Code(s): 63736-050-01
- Packager: Insight Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 11, 2017
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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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.
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INGREDIENTS AND APPEARANCE
MONISTAT CARE INSTANT ITCH RELIEF
benzocaine sprayProduct 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)