UNIVERSAL BABY FRESH SCENT 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 BABY FRESH SCENT PETROLEUM

Active ingredient

White Petrolatum USP (99.9 %)

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

Fragrance

PRINCIPAL DISPLAY PANEL

Universal Baby fresh Scent Petroleum
Jelly
Net Wt. 13 OZ (368 g)

Label

UNIVERSAL BABY FRESH SCENT PETROLEUM 
white petroleum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-118
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52000-118-01170 g in 1 JAR; Type 0: Not a Combination Product11/01/2019
2NDC:52000-118-02226 g in 1 JAR; Type 0: Not a Combination Product11/01/2019
3NDC:52000-118-03368 g in 1 JAR; Type 0: Not a Combination Product11/01/2019
4NDC:52000-118-04510 g in 1 JAR; Type 0: Not a Combination Product11/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/01/2019
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Jell Pharmaceuticals Pvt Ltd. (726025211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt Ltd726025211manufacture(52000-118)

Revised: 11/2022
Document Id: ec67a1ee-ad72-54f2-e053-2995a90a7690
Set id: ec67a1ee-ad71-54f2-e053-2995a90a7690
Version: 3
Effective Time: 20221101
 
Universal Distribution Center LLC