Touchless Care Antifungal Spray

Touchless Care Antifungal Spray
SPL v1
SPL
SPL Set ID 48a7a01e-3480-45bf-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2017-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Lanolin Vitamin A Palmitate Mineral Oil Dimethicone Cyclomethicone Petrolatum Zinc Oxide Hexamethyldisiloxane Cholecalciferol Microcrystalline Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-02-28

Description

Miconazole Nitrate 2%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Miconazole Nitrate 2%

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.

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

Antifungal label

Active Ingredient

Miconazole Nitrate 2%

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

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 poison control center immediately.


Structured Label Content

Purpose

Antifungal

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.

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

Antifungal label

Active Ingredient

Miconazole Nitrate 2%

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 (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

Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

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


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