RASH RELIEF- zinc oxide dimethicone spray

Rash Relief by

Drug Labeling and Warnings

Rash Relief 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

Dimethicone             20%       

Zinc Oxide               25%

Purpose

Skin Protectant

Uses: Treats and prevents minor skin irritation - itching - diaper rash - feeding tubes sites, or lacerations.

Warnings

- Do not use over deep or puncture wounds, infections, or lacerations.  For external use only.

- When using this product do not get into eyes.  If contact occurs, rinse eyes throughout with water.

- Stop use and ask a doctor if condition worsens or does not improve with 7 days.

Directions

- Cleanse skin area, and allow to dry.

- Shake bottle well before use.

- Spray 4-6 inches from skin.  No rub-in is required.

- Apply liberally as often as necessary- each diaper change with incontinence care- to soothe and protect irritated skin.

Inactive Ingredients

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

INDICATIONS & USAGE

Uses: Treats and prevents minor skin irritation - itching - diaper rash - feeding tubes sites, or lacerations.

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 
zinc oxide dimethicone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15071-604
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	25 g  in 100 g
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	20 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: 15071-604-11	56 g in 1 BOTTLE, SPRAY
2	NDC: 15071-604-22	128 g in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/21/2005

Labeler - Touchless Care Concepts LLC (083459334)

Registrant - Touchless Care Concepts LLC (083459334)