RASH RELIEF ANTIFUNGAL- miconazole liquid

Rash Relief Antifungal by

Drug Labeling and Warnings

Rash Relief Antifungal by is a Otc medication manufactured, distributed, or labeled by Touchless Care Concepts LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INDICATIONS & USAGE

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

KEEP OUT OF REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RASH RELIEF ANTIFUNGAL 
miconazole liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15071-804
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Touchless Care Concepts LLC (083459334)

Registrant - Touchless Care Concepts LLC (083459334)