UNIVERSAL PURE PETROLEUM- 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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Universal Petroleum Jelly (regular)

Active ingredient

White Petrolatum USP (100 %)

Purpose

Skin Protectant

Uses

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)

PRINCIPAL DISPLAY PANEL 100% PURE PETROLEUM JELLY Net Wt. 8 fl. oz. (250g) 8 onzas

UNIVERSAL PURE PETROLEUM 
white petroleum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-005
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:52000-005-19226 g in 1 JAR; Type 0: Not a Combination Product11/07/2022
2NDC:52000-005-2045 g in 1 JAR; Type 0: Not a Combination Product11/07/2022
3NDC:52000-005-21100 g in 1 JAR; Type 0: Not a Combination Product11/07/2022
4NDC:52000-005-22113 g in 1 JAR; Type 0: Not a Combination Product11/07/2022
5NDC:52000-005-23170 g in 1 JAR; Type 0: Not a Combination Product11/07/2022
6NDC:52000-005-24198 g in 1 JAR; Type 0: Not a Combination Product11/07/2022
7NDC:52000-005-25283 g in 1 JAR; Type 0: Not a Combination Product11/07/2022
8NDC:52000-005-26368 g in 1 JAR; Type 0: Not a Combination Product11/07/2022
9NDC:52000-005-27450 g in 1 JAR; Type 0: Not a Combination Product11/07/2022
10NDC:52000-005-28500 g in 1 JAR; Type 0: Not a Combination Product11/07/2022
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(52000-005)

Revised: 11/2022
Document Id: eca06bfc-2c54-2ce0-e053-2995a90a79a9
Set id: 6bc34bbe-e324-48f4-b6df-dd508b19c2e2
Version: 4
Effective Time: 20221104
 
Universal Distribution Center LLC