RASH RELIEF - zinc oxide dimethicone spray 
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

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


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

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


RR25

RASH RELIEF 
zinc oxide dimethicone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15071-604
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide25 g  in 100 g
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15071-604-1156 g in 1 BOTTLE, SPRAY
2NDC:15071-604-22128 g in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/21/2005
Labeler - Touchless Care Concepts LLC (083459334)
Registrant - Touchless Care Concepts LLC (083459334)

Revised: 10/2011
Document Id: 807982a5-c00f-476e-a20e-3315826756ba
Set id: 54d7250e-6aaa-4fc8-88b3-2fee58ebaf73
Version: 1
Effective Time: 20111018
 
Touchless Care Concepts LLC