RASH RELIEF ANTIBACTERIAL - bacitracin dimethicone zinc oxide 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 ANTIBACTERIAL SPRAY

Active Ingredients

Bacitracin               500 units/g

Dimethicone             20%       

Petrolatum               25%


Purpose

Antibacterial / Skin Protectant

Warnings

- Do not use over deep or puncture wounds, infections, or lacerations.  Do not apply over large areas of the body.

- When using this product do not get into eyes.  If contact occurs, rinse eyes thoroughly with water.  For external use only. 

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

Directions

- Cleanse the 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 to soothe and protect irritated skin.


Inactive Ingredients

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


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


Uses: First aid to help prevent infection in minor cuts, scrapes, and burns.  Treats and prevents minor skin irritation: itching, diaper rash, feeding tube sites, cuts, and minor burns.

RRABSPRAYEnter section text here

RASH RELIEF ANTIBACTERIAL 
bacitracin dimethicone zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15071-672
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin (UNII: 58H6RWO52I) (Bacitracin - UNII:58H6RWO52I) Bacitracin500 [iU]  in 1 g
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone20 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Cyclomethicone (UNII: NMQ347994Z)  
Mineral Oil (UNII: T5L8T28FGP)  
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:15071-672-1128 g in 1 BOTTLE
2NDC:15071-672-2244 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B06/14/2006
Labeler - Touchless Care Concepts LLC (083459334)
Registrant - Touchless Care Concepts LLC (083459334)

Revised: 11/2011
Document Id: 24e155fd-dad7-4d37-a12d-0c18fc624481
Set id: f439fb97-0722-42ee-bc90-67daf0497aa8
Version: 2
Effective Time: 20111116
 
Touchless Care Concepts LLC