UNIVERSAL BABY FRESH SCENT PETROLEUM- petrolatum 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 (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

None

PRINCIPAL DISPLAY PANEL

UNIVERSAL BABY FRESH SCENT PETROLEUM
SKIN PROTECTANT
NET WT. 13 OZ (368 g)

Label

UNIVERSAL BABY FRESH SCENT PETROLEUM 
white petroleum jelly
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52000-006
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 0.99 g  in 1 g
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52000-006-19 226 g in 1 JAR
2 NDC:52000-006-20 45 g in 1 JAR
3 NDC:52000-006-21 100 g in 1 JAR
4 NDC:52000-006-22 113 g in 1 JAR
5 NDC:52000-006-23 170 g in 1 JAR
6 NDC:52000-006-24 198 g in 1 JAR
7 NDC:52000-006-25 283 g in 1 JAR
8 NDC:52000-006-26 368 g in 1 JAR
9 NDC:52000-006-27 450 g in 1 JAR
10 NDC:52000-006-28 500 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part347 02/06/2013
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
Name Address ID/FEI Business Operations
Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture(52000-006)

Revised: 2/2013
Document Id: c3b383bd-a87f-48e2-b66a-33f37a741924
Set id: 834dff7a-dba6-427a-ad20-c2648739aa1e
Version: 2
Effective Time: 20130208
 
Universal Distribution Center LLC