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WHITE PETROLATUM by Sion Biotext Medical Ltd

Dosage form: jelly
Ingredients: PETROLATUM 1g in 1g
Labeler: Sion Biotext Medical Ltd
NDC Code: 68786-211

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.

Petrolatum Jelly

Active Ingredient

White Petrolatum (USP, 100%  w/w)                    


Skin Protectant

  • 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.


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.

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

Other information:
  • Store at 59 Deg F - 86 Deg F (15 - 30 Deg C)
  • Avoid excessive heat.

Principal Display Panel



Made in Israel

petrolatum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68786-211
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
#Item CodePackage Description
1NDC:68786-211-016 BOX (BOX) in 1 CASE
15 g in 1 PACKET
2NDC:68786-211-0272 BOX (BOX) in 1 CASE
21 TUBE (TUBE) in 1 BOX
228.35 g in 1 TUBE
3NDC:68786-211-03100 TUBE (TUBE) in 1 CASE
328.35 g in 1 TUBE
4NDC:68786-211-0472 BOX (BOX) in 1 CASE
41 TUBE (TUBE) in 1 BOX
456.7 g in 1 TUBE
5NDC:68786-211-0572 BOX (BOX) in 1 CASE
51 TUBE (TUBE) in 1 BOX
592 g in 1 TUBE
6NDC:68786-211-06100 TUBE (TUBE) in 1 CASE
692 g in 1 TUBE
7NDC:68786-211-076 BOX (BOX) in 1 CASE
712 TUBE (TUBE) in 1 BOX
7113 g in 1 TUBE
8NDC:68786-211-08100 TUBE (TUBE) in 1 CASE
8113 g in 1 TUBE
9NDC:68786-211-0912 JAR (JAR) in 1 CASE
9425 g in 1 JAR
10NDC:68786-211-1024 TUBE (TUBE) in 1 CASE
10284 g in 1 TUBE
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)
Sion Biotext Medical Ltd532775194manufacture(68786-211)

Revised: 02/2014
Sion Biotext Medical Ltd

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.