Label: RASH RELIEF CLEAR- petrolatum dimethicone liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated November 14, 2011

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  • 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

  • INDICATIONS & USAGE

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

  • 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

    RRCLEnter section text here

  • INGREDIENTS AND APPEARANCE
    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)
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