TOUCHLESS CARE ANTIFUNGAL- touchless care antifungal spray 
Crawford Healthcare, Inc.

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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Touchless Care ANTIFUNGAL SPRAY

Active Ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Indications

Warnings

Do not use on children under 2 years of age unless directed by a doctor. Not intended for ingestion. Do not use for diaper rash. For external use only. When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center immediately.

Directions

Other Information

Store at 59 oF - 87 oF (15 oC - 30 oC)

Inactive Ingredients

Cyclomethicone, Dimethicone, Hexamethyldisiloxane, Lanolin, Light Mineral Oil, Microcrystalline Wax, Vitamin A Palmitate, Vitamin D3, White Petrolatum, Zinc Oxide

SPL Unclassified Section

Distributed by: Crawford Healthcare, Inc. Doylestown, PA 18901

Touchless Care is a registered trademark of Crawford Woundcare Ltd.

© Crawford Healthcare Ltd., 2016

www.crawfordhealthcare.com/us

1-855-522-2211

Made in the USA

Package Label

Antifungal label

antifungal label

TOUCHLESS CARE ANTIFUNGAL 
touchless care antifungal spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69502-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN (UNII: 7EV65EAW6H)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
MINERAL OIL (UNII: T5L8T28FGP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
PETROLATUM (UNII: 4T6H12BN9U)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69502-001-5757 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/28/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C02/28/2017
Labeler - Crawford Healthcare, Inc. (042813710)

Revised: 2/2017
Document Id: 48a7a01e-3481-45bf-e054-00144ff88e88
Set id: 48a7a01e-3480-45bf-e054-00144ff88e88
Version: 1
Effective Time: 20170216
 
Crawford Healthcare, Inc.