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Royal Petroleum Jelly with Cocoa Butter Scent

Dosage form: jelly
Ingredients: PETROLATUM 99.9g in 100g
Labeler: Royal Exports
NDC Code: 51328-1011

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 Ingredient

White Petrolatum (99.9 w/w)

Purpose

Skin Protectant

Uses
  • temporarily protects minor cuts, scrapes,burns
  • temporarily protects and helps relieve chapped or cracked skin
  • helps protect from the drying effects of wind and cold weather
  • helps treat and prevent and prevent diaper rash
  • helps seal out wetness

Warnings

FOR EXTERNAL USE ONLY

When using this product
  • do not get into eyes

Stop use and ask a doctor if
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again with a few days

Do not use on
  • deep or puncture wounds
  • animal bites
  • serious burns

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

Directions
  • Apply as needed

Inactive Ingredient

Fragnance

ROYAL PETROLEUM JELLY WITH COCOA BUTTER SCENT 
petrolatum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51328-1011
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM99.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage Description
1NDC:51328-1011-3226 g in 1 JAR
2NDC:51328-1011-5368 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/10/2016
Labeler - Royal Exports (918583790)

Revised: 12/2017
 
Royal Exports

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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