PETROLATUM by Dynarex Corporation / Galentic PharmaIndia Private Limited / Amar Remedies Limited PETROLATUM jelly

PETROLATUM by

Drug Labeling and Warnings

PETROLATUM by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation, Galentic PharmaIndia Private Limited, Amar Remedies Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                            Purpose

White Petrolatum 100%                 Skin Protectant            

Uses:

• Helps treat and prevent diaper rash
• Helps seal out wetness
• Temporarily protects minor * cuts * scrapes * burns
• Temporarily helps protect and helps relieve chapped and cracked skin and lips
• Helps prevent and protect from the drying effects of wind and cold weather
• Helps prevent and protect chaffed skin or minor skin irritations associated with diaper rash
• With each diaper change, especially at bed time when exposure to wet diapers may be prolonged.
  

Warnings:

For external use only.

When using this product:

Do not get in eyes.

Stop use and ask a doctor if:

• Condition worsens
• symptoms last more than 7 days or clear up and occur in a few days.
  

Do not use on:

• Deep or 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 room temperature 15 Deg C - 30 Deg C (59 Deg F - 86 Deg F)
• Avoid excessive heat 

Indications and Usage

Skin Protectant

Principal Display Panel:

Petrolatum_Jelly.jpg

INGREDIENTS AND APPEARANCE

PETROLATUM 
petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-400
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: 67777-400-01	12 in 1 CASE
1		6 in 1 BOX
1		113.4 g in 1 TUBE
2	NDC: 67777-400-02	12 in 1 CASE
2		6 in 1 BOX
2		28.35 g in 1 TUBE
3	NDC: 67777-400-03	12 in 1 CASE
3		6 in 1 BOX
3		58.7 g in 1 TUBE
4	NDC: 67777-400-04	12 in 1 CASE
4		425.2 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/23/2010

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124539)

Establishment
Name	Address	ID/FEI	Business Operations
Galentic PharmaIndia Private Limited		918531450	manufacture(67777-400)

Establishment
Name	Address	ID/FEI	Business Operations
Amar Remedies Limited		915839811	manufacture(67777-400)