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Petroleum Jelly by Rejoice International Inc.

Dosage form: cream
Ingredients: PETROLATUM 99g in 100g
Labeler: Rejoice International Inc.
NDC Code: 57337-077

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.

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 apply as needed

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

  • deep puncture wounds
  • animal bites
  • serious burns

Inactive ingredients fragrance

PETROLEUM JELLY 
white petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-077
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM99 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage Description
1NDC:57337-077-01113 g in 1 PACKAGE
2NDC:57337-077-02170 g in 1 PACKAGE
3NDC:57337-077-03227 g in 1 PACKAGE
4NDC:57337-077-04368 g in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/15/2015
Labeler - Rejoice International Inc. (078741245)
Establishment
NameAddressID/FEIOperations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(57337-077)

Revised: 09/2015
 
Rejoice International Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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