TOUCHLESS CARE ANTIFUNGAL- miconazole nitrate 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.

----------

Touchless Care Antifungal Spray

Active Ingredients

Miconazole Nitrate 2%

Purpose

Antifungal

Indications

Treats jock itch, ringworm, and athlete's foot.
For the treatment of most superficial skin irritations cause by yeast (Candida albicans).
Follow a physician’s instructions when treating Candida.

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

■ irritation develops

■ there is no improvement within 4 weeks for athlete’s foot or ringworm or within 2 weeks for jock itch.

Keep out of reach of children.

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

Directions

■ Cleanse the affected area and allow to dry.

■ Shake bottle well before use.

■ Spray 4-6 inches from skin twice daily (morning and night) or as directed by a physician. No rub-in is required.

■ For athlete’s foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks. If condition persists longer, contact a doctor.

■ This product is not effective on the scalp or nails.

Other Information

Store at 59° F - 87° F (15° C - 30° C)

Inactive Ingredients

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

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

Touchless Care is a registered trademark of Crawford

Healthcare, Inc. © Copyright Crawford Healthcare Ltd, 2014

www.crawfordhealthcare.com

■ 1-855-522-2211

Made in the USA Issue 1 - Oct. 2014

Package Label

antifungal spray

TOUCHLESS CARE ANTIFUNGAL
miconazole nitrate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69502-500
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE (UNII: NMQ347994Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
LANOLIN (UNII: 7EV65EAW6H)
MINERAL OIL (UNII: T5L8T28FGP)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
ZINC OXIDE (UNII: SOI2LOH54Z)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69502-500-57	57 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/29/2016	08/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	12/29/2014	08/31/2019

Labeler - Crawford Healthcare, Inc. (042813710)

Name	Address	ID/FEI	Business Operations
Establishment
Cosmetic Creations Inc.		079375497	manufacture(69502-500)

Revised: 10/2017

Document Id: 5c4fd5c0-8712-1796-e053-2a91aa0a5b34

Set id: e7ef0d67-f3ef-41e0-89cf-5eaef013f067

Version: 5

Effective Time: 20171024

Crawford Healthcare, Inc.