BABY PETROLEUM JELLY- white petrolatum cream 
Rejoice International Inc.

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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Baby Petroleum Jelly

Active Ingredients                      Purpose

White Petroleum 99.9% ...... skin protectant

Uses

temporarily protects and helps relieve chapped or cracked skin and lips

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

XtraCare

100% Pure Petroleum Jelly

Baby Fresh Scent

Directions

Warnings

For external use only

When using this product do not get into eyes

See a doctor if condition lasts more than 7 days

Do not use on

Inactive ingredients fragrance

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BABY PETROLEUM JELLY 
white petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-076
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57337-076-01113 g in 1 PACKAGE; Type 0: Not a Combination Product06/15/2015
2NDC:57337-076-02170 g in 1 PACKAGE; Type 0: Not a Combination Product06/15/2015
3NDC:57337-076-03227 g in 1 PACKAGE; Type 0: Not a Combination Product06/15/2015
4NDC:57337-076-04368 g in 1 PACKAGE; Type 0: Not a Combination Product06/15/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/15/2015
Labeler - Rejoice International Inc. (078741245)
Registrant - Jell Pharmaceuticals Pvt Ltd. (726025211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(57337-076)

Revised: 11/2022
Document Id: edbf1175-173c-ca65-e053-2995a90a73c8
Set id: caf568aa-3889-41ff-835e-875bb6d9ca79
Version: 5
Effective Time: 20221118
 
Rejoice International Inc.