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PETROLATUM by Dynarex Corporation

Dosage form: jelly
Ingredients: PETROLATUM 1g in 1g
Labeler: Dynarex Corporation
NDC Code: 67777-400

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                            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

PETROLATUM 
petrolatum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-400
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM1 g  in 1 g
Packaging
#Item CodePackage Description
1NDC:67777-400-0112 BOX (BOX) in 1 CASE
16 TUBE (TUBE) in 1 BOX
1113.4 g in 1 TUBE
2NDC:67777-400-0212 BOX (BOX) in 1 CASE
26 TUBE (TUBE) in 1 BOX
228.35 g in 1 TUBE
3NDC:67777-400-0312 BOX (BOX) in 1 CASE
36 TUBE (TUBE) in 1 BOX
358.7 g in 1 TUBE
4NDC:67777-400-0412 JAR (JAR) in 1 CASE
4425.2 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/23/2010
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
NameAddressID/FEIOperations
Galentic PharmaIndia Private Limited918531450manufacture(67777-400)
Establishment
NameAddressID/FEIOperations
Amar Remedies Limited915839811manufacture(67777-400)

Revised: 12/2012
 
Dynarex Corporation

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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.

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