WHITE PETROLATUM- petrolatum jelly

WHITE PETROLATUM by

Drug Labeling and Warnings

WHITE PETROLATUM by is a Otc medication manufactured, distributed, or labeled by Sion Biotext Medical Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.
  

SPL UNCLASSIFIED SECTION

Principal Display Panel

WHITE PETROLATUM (USP)

SKIN PROTECTANT

Made in Israel

INGREDIENTS AND APPEARANCE

WHITE PETROLATUM 
petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68786-211
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	1 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68786-211-01	6 in 1 CASE	02/16/2014
1		144 in 1 BOX
1		5 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 68786-211-02	72 in 1 CASE	02/16/2014
2		1 in 1 BOX
2		28.35 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 68786-211-03	100 in 1 CASE	02/16/2014
3		28.35 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 68786-211-04	72 in 1 CASE	02/16/2014
4		1 in 1 BOX
4		56.7 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 68786-211-05	72 in 1 CASE	02/16/2014
5		1 in 1 BOX
5		92 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 68786-211-06	100 in 1 CASE	02/16/2014
6		92 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC: 68786-211-07	6 in 1 CASE	02/16/2014
7		12 in 1 BOX
7		113 g in 1 TUBE; Type 0: Not a Combination Product
8	NDC: 68786-211-08	100 in 1 CASE	02/16/2014
8		113 g in 1 TUBE; Type 0: Not a Combination Product
9	NDC: 68786-211-09	12 in 1 CASE	02/16/2014
9		425 g in 1 JAR; Type 0: Not a Combination Product
10	NDC: 68786-211-10	24 in 1 CASE	02/16/2014
10		284 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/16/2014

Labeler - Sion Biotext Medical Ltd (532775194)

Registrant - Sion Biotext Medical Ltd (532775194)

Establishment
Name	Address	ID/FEI	Business Operations
Sion Biotext Medical Ltd		532775194	manufacture(68786-211)