WHITE PETROLATUM (PETROLATUM) JELLY [SION BIOTEXT MEDICAL LTD]

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WHITE PETROLATUM (PETROLATUM) JELLY [SION BIOTEXT MEDICAL LTD]
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NDC 68786-211-01, 68786-211-02, 68786-211-03, 68786-211-04, 68786-211-05, 68786-211-06, 68786-211-07, 68786-211-08, 68786-211-09, 68786-211-10
Set ID 53ca3aeb-1d5d-4964-adb5-1cfa901642da
Category HUMAN OTC DRUG LABEL
Packager Sion Biotext Medical Ltd
Generic Name
Product Class
Product Number
Application Number PART347
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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)
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