RASH RELIEF ANTIFUNGAL - miconazole liquid
Touchless Care Concepts LLC

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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RASH RELIEF ANTIFUNGAL SPRAY

Active Ingredients

Miconazole Nitrate 2%

Dimethicone 10%

Petrolatum 10%

Purpose

Antifungal / Skin Protectant

Warnings

- Ask a doctor before use on children under the age of two. For external use only.

- When using this product do not get into eyes.

- 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.

Directions

- Clean the affected area and dry thoroughly.

- 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.

Inactive Ingredients

Cyclomethicone, Hexamethyldisiloxane, Lanolin, Light Mineral Oil, Microcrystalline Wax, Vitamin A Palmitate, Vitamin D3, Water, White Petrolatum

Uses: Treats jock itch, ringworm, and athlete's foot

- Keep out of reach of children. If swallowed, get medical help or contact a local poison control center immediately

RRAF

RASH RELIEF ANTIFUNGAL
miconazole liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:15071-804
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
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	10 g in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	10 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
Mineral Oil (UNII: T5L8T28FGP)
Cyclomethicone (UNII: NMQ347994Z)
Lanolin (UNII: 7EV65EAW6H)
Microcrystalline Wax (UNII: XOF597Q3KY)
Hexamethyldisiloxane (UNII: D7M4659BPU)
Water (UNII: 059QF0KO0R)
Cholecalciferol (UNII: 1C6V77QF41)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Petrolatum (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:15071-804-11	56 g in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	06/14/2006

Labeler - Touchless Care Concepts LLC (083459334)

Registrant - Touchless Care Concepts LLC (083459334)