RASH RELIEF CLEAR - petrolatum dimethicone 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 CLEAR SPRAY

Active Ingredients

Dimethicone             20%       

Petrolatum               25%


Purpose

Skin Protectant

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

- Change wet and soiled diapers promptly, cleanse the diaper 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, with each diaper change, and especially at bedtime or anytime exposure to we diapers is prolonged.

Inactive Ingredients

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

Uses: Protects minor skin irritation due to diaper rash and helps seal out wetness.

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

RRCLEnter section text here

RASH RELIEF CLEAR 
petrolatum dimethicone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15071-704
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum25 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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15071-704-1155 g in 1 BOTTLE
2NDC:15071-704-22100 g in 1 BOTTLE
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: 11/2011
Document Id: f678f128-0e58-49db-a47d-21ab8f8c74a3
Set id: 0b5753aa-b591-4d6e-8341-fcc9456299b6
Version: 2
Effective Time: 20111114
 
Touchless Care Concepts LLC