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UNIVERSAL PURE PETROLEUM

Dosage form: jelly
Ingredients: PETROLATUM 1g in 1g
Labeler: Universal Distribution Center LLC
NDC Code: 52000-005

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.

Active ingredient

White Petrolatum USP (100 %)

Purpose

Skin Protectant

Uses

  • For the temporary protection of minor cuts, scrapes, burns and sunburn.
  • Helps to temporarily protect chafed, chapped, cracked or windburned skin and lips.

Warnings

For External Use Only.

Do not use over deep or puncture wounds, infections or lacerations. Ask a doctor.

When using this product avoid contact with eyes.

Stop use and ask doctor if condition worsens or does not improve within 7 days.

Keep out of reach of children if swallowed get medical help or contact a Poison Control Center right away.

Directions

Apply product as liberally, as often as necessary.

Inactive ingredients

None

PRINCIPAL DISPLAY PANEL

UNIVERSAL PURE PETROLEUM JELLY
SKIN PROTECTANT
NET WT. 13 OZ (368 g)

UNIVERSAL PURE PETROLEUM 
white petroleum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-005
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM1 g  in 1 g
Packaging
#Item CodePackage Description
1NDC:52000-005-19226 g in 1 JAR
2NDC:52000-005-2045 g in 1 JAR
3NDC:52000-005-21100 g in 1 JAR
4NDC:52000-005-22113 g in 1 JAR
5NDC:52000-005-23170 g in 1 JAR
6NDC:52000-005-24198 g in 1 JAR
7NDC:52000-005-25283 g in 1 JAR
8NDC:52000-005-26368 g in 1 JAR
9NDC:52000-005-27450 g in 1 JAR
10NDC:52000-005-28500 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34702/06/2013
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
NameAddressID/FEIOperations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52000-005)

Revised: 02/2013
 
Universal Distribution Center LLC

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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