Label: RENEWAL MEDICATED- menthol - dimethicone lotion

  • 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 July 14, 2010

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  • ACTIVE INGREDIENTS

    • MENTHOL 0.5% (TOPICAL ANALGESIC)
    • DIMETHICONE 5.0% (SKIN PROTECTANT)
  • USES AND DIRECTIONS

    • USES: TO HELP MOISTURIZE, RELIEVE AND PROTECT DRY/ITCHY SKIN. RECOMMENDED FOR REPEATED USE.
    • DIRECTIONS: APPLY TO DRY, ITCHY SKIN AS OFTEN AS NEEDED
  • WARNINGS

    • FOR EXTERNAL USE ONLY.

    WHEN USING THIS PRODUCT

    • AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

    STOP USING THIS PRODUCT AND ASK A DOCTOR IF

    • IRRITATION OR REDNESS DEVELOPS AND LASTS.

    KEEP OUT OF REACH OF CHILDREN

    • IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
  • QUESTIONS/COMMENTS?

    1-866-695-3030

  • PACKAGE FRONT AND BACK LABELS (14OZ)

    • 14OZ FRONT AND BACK LABELS: ra14.jpg
      FRONT AND BACK LABELS
  • INGREDIENTS AND APPEARANCE
    RENEWAL  MEDICATED
    menthol - dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-3351
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 mL  in 100 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE5.0 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-3351-4414 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/14/2010
    Labeler - RITE AID (014578892)
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