Drug Labeling and Warnings

Drug Details

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UNIVERSAL PURE PETROLEUM COCOA BUTTER SCENTED- white petroleum jelly 
Universal Distribution Center LLC

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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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 COCOA BUTTER SCENTED JELLY
SKIN PROTECTANT
NET WT. 13 OZ (368 g)

Label

UNIVERSAL PURE PETROLEUM COCOA BUTTER SCENTED 
white petroleum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 52000-007
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: 52000-007-19226 g in 1 JAR
2NDC: 52000-007-2045 g in 1 JAR
3NDC: 52000-007-21100 g in 1 JAR
4NDC: 52000-007-22113 g in 1 JAR
5NDC: 52000-007-23170 g in 1 JAR
6NDC: 52000-007-24198 g in 1 JAR
7NDC: 52000-007-25283 g in 1 JAR
8NDC: 52000-007-26368 g in 1 JAR
9NDC: 52000-007-27450 g in 1 JAR
10NDC: 52000-007-28500 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/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52000-007)

Revised: 2/2013
 
Universal Distribution Center LLC


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