Label: SKIN CARE LOTION EXTRA STRENGTH- 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 June 25, 2010

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  • ACTIVE INGREDIENT

    DIMETHICONE 1.0% (SKIN PROTECTANT)

  • WARNING

    FOR EXTERNAL USE ONLY.

    AVOID CONTACT WITH EYES, IF CONTACT OCCURS, RINSE EYE THROUGHLY WITH WATER.

    STOP USING THIS PRODUCT AND ASK A DOCTOR IF

    CONDITION WORSENS OR SYMPTOMS PERSIST FOR MORE THAN SEVEN DAYS OR OCCUR AGAIN WITHIN A FEW DAYS.

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • USES

    HELPS PREVENT AND TEMPORARILY PROTECTS CHAFED, CHAPPED OR CRACKED SKIN.

  • FRONT AND BACK LABELS

    24OZ FRONT AND BACK LABELS: K24.jpgFRONT AND BACK LABELS

  • INGREDIENTS AND APPEARANCE
    SKIN CARE LOTION  EXTRA STRENGTH
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59450-310
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.0000 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59450-310-24709 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/25/2010
    Labeler - THE KROGER CO (006999528)
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