Label: HYDRATING HEALING DAILY THRAPY- petrolatum ointment

  • 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 19, 2010

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  • ACTIVE INGREDIENT

    • PETROLATUM 41% ( SKIN PROTECTANT)
  • USES AND DIRECTIONS

    USES:
    • TEMPORARILY PROTECTS MINOR 'CUTS' SCRAPS 'BURNS
    • TEMPORARILY PROTECTS AND HELPS RELIEVE CHAPPED OR CRACKED SKIN AND LIPS
    • HELPS PROTECT FROM THE DRYING EFFECTS OF COLD WIND AND WEATHER
    DIRECTIONS: APPLY AS REQUIRED.
  • WARNINGS

    • FOR EXTERNAL USE ONLY.

    WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYE THOROUGHLY 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 FEW DAYS.

    DO NOT USE

    • ON DEEP OR PUNCTURED WOUNDS, OR ON ANIMAL BITE, OR ON SERIOUS BURNS
    • IF INNER SEAL IS MISSING OR BROKEN

    KEEP OUT OF REACH OF CHILDREN

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

  • FRONT AND BACK LABELS

    14oz front and back labels: care14.jpg14OZ FRONT AND BACK LABELS


  • INGREDIENTS AND APPEARANCE
    HYDRATING HEALING  DAILY THRAPY
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-330
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM41.000 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63148-330-14396 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/19/2010
    Labeler - APOLLO HEALTH AND BEAUTY CARE (201901209)
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