Label: WHITE PETROLATUM- petrolatum jelly

  • NDC Code(s): 68786-211-01, 68786-211-02, 68786-211-03, 68786-211-04, view more
    68786-211-05, 68786-211-06, 68786-211-07, 68786-211-08, 68786-211-09, 68786-211-10
  • Packager: Sion Biotext Medical Ltd
  • Category: HUMAN OTC DRUG LABEL

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 11, 2020

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  • Active Ingredient

    White Petrolatum (USP, 100%  w/w)                    

  • Purpose

    Skin Protectant

  • Uses:

    • Helps treat and prevent diaper rash
    • Helps seal out wetness
    • Temporarily protects minor * cuts * scrapes * burns
    • Temporarily helps protect and relieve chapped and cracked skin or lips
    • Helps prevent and protect chafed skin or minor skin irritations associated with diaper rash
    • With each diaper change, especially at bedtime when exposure to wet diapers may be prolonged.
  • 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 in a few days.

    Do not use on

    • deep puncture wounds
    • animal bites
    • serious burns.

    Keep out of reach of children.

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

  • Directions:

    • Change wet and soiled diapers promptly.
    • Cleanse the diaper area and allow to dry.
    • Apply as needed.
  • Other Information

    • Store at 59-86°F (15-30°C)
    • Avoid excessive heat
  • Principal Display Panel

    WHITE PETROLATUM (USP)

    SKIN PROTECTANT

    Made in Israel

    Label

    Label 1

  • INGREDIENTS AND APPEARANCE
    WHITE PETROLATUM 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68786-211
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM1 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68786-211-016 in 1 CASE02/16/2014
    1144 in 1 BOX
    15 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:68786-211-0272 in 1 CASE02/16/2014
    21 in 1 BOX
    228.35 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:68786-211-03100 in 1 CASE02/16/2014
    328.35 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:68786-211-0472 in 1 CASE02/16/2014
    41 in 1 BOX
    456.7 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:68786-211-0572 in 1 CASE02/16/2014
    51 in 1 BOX
    592 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:68786-211-06100 in 1 CASE02/16/2014
    692 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:68786-211-076 in 1 CASE02/16/2014
    712 in 1 BOX
    7113 g in 1 TUBE; Type 0: Not a Combination Product
    8NDC:68786-211-08100 in 1 CASE02/16/2014
    8113 g in 1 TUBE; Type 0: Not a Combination Product
    9NDC:68786-211-0912 in 1 CASE02/16/2014
    9425 g in 1 JAR; Type 0: Not a Combination Product
    10NDC:68786-211-1024 in 1 CASE02/16/2014
    10284 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/16/2014
    Labeler - Sion Biotext Medical Ltd (532775194)
    Registrant - Sion Biotext Medical Ltd (532775194)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Biotext Medical Ltd532775194manufacture(68786-211)