WHITE PETROLATUM- petrolatum jelly 
Sion Biotext Medical Ltd

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Petrolatum Jelly

Active Ingredient

White Petrolatum (USP, 100%  w/w)                    

Purpose

Skin Protectant

Uses:

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:

Other Information

Inactive Ingredients

None

Principal Display Panel

WHITE PETROLATUM (USP)

SKIN PROTECTANT

Made in Israel

Label

Label 1

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 DrugM01602/16/2014
Labeler - Sion Biotext Medical Ltd (532775194)
Registrant - Sion Biotext Medical Ltd (532775194)
Establishment
NameAddressID/FEIBusiness Operations
Sion Biotext Medical Ltd532775194manufacture(68786-211)

Revised: 2/2024
Document Id: 12740b6c-1920-9d41-e063-6394a90a1960
Set id: 53ca3aeb-1d5d-4964-adb5-1cfa901642da
Version: 14
Effective Time: 20240228
 
Sion Biotext Medical Ltd