Label: HYDRATING HEALING SKIN PROTECTANT- petrolatum ointment 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 January 29, 2021

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  • Active Ingredient

    Petrolatum 41%

  • Purpose

    Skin protectant (ointment) Treatment or prevention of diaper rash

  • Uses

    temporarily protects minor: cuts, scrapes, burns

    temporarily protects and helps relieve chapped or cracked skin and lips

    helps protect from the drying effects of wind and cold weather

    helps treat and prevent diaper rash

    protects chafed skin associated with diaper rash and helps protect from wetness

  • Warnings

    For external use only

  • When using this product

    do not get into eyes

  • Stop use and ask a doctor if

    condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

  • Do not use on

    For external use only.  Avoid contact with eyes.  Do not use on serious burns, puncture wounds or animal bites.  If condition does not improve within seven days, consult a doctor.

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    apply as needed

    for diaper rash, change wet and soiled diapers promptly, cleanse the diaper area and allow to dry.  Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

  • Inactive ingredients

    Mineral Oil, Ceresin, Lanolin Alcohol, Panthenol, Glycerin, Bisabolol

  • Tube Label

    Label

  • Carton Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    HYDRATING HEALING SKIN PROTECTANT 
    petrolatum ointment ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-853
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM41 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP) 35 g  in 100 g
    CERESIN (UNII: Q1LS2UJO3A) 7 g  in 100 g
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE) 3 g  in 100 g
    PANTHENOL (UNII: WV9CM0O67Z) 0.1 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 13.8 g  in 100 g
    .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) 0.1 g  in 100 g
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-853-022 in 1 CARTON08/06/2017
    1NDC:59779-853-019.9 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/06/2017
    Labeler - CVS Pharmacy (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack, Inc.009248480manufacture(59779-853)
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