Petrolatum Jelly

Petrolatum Jelly

Drug Labeling and Warnings

Drug Details

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WHITE PETROLATUM- petrolatum jelly 
Sion Biotext Medical Ltd

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.

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Petrolatum Jelly

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 Deg F - 86 Deg F (15 - 30 Deg C)
  • Avoid excessive heat.

Principal Display Panel

WHITE PETROLATUM (USP)

SKIN PROTECTANT

Made in Israel

image description

image description

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)

Revised: 8/2019
 
Sion Biotext Medical Ltd


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