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Petrocort Antipruritic Lip 21

Medically reviewed on January 17, 2018.

Dosage form: lipstick
Ingredients: HYDROCORTISONE 0.005g in 1g
Labeler: Clinical Formula LLC
NDC Code: 51822-021

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.

Petrocort Antipruritic Lip Balm #21

Drug Facts

Active Ingredient (in percentage)

Hydrocortisone 0.5%

Purpose

For relief of minor skin irritation.

USES:

Adults and children 5 years and over: For the temporary relief of minor skin irritations and rashes. Help prevent and temporarily protect chafed, chapped, cracked, windburned or sunburned lips.

WARNINGS:

For external use only. If condition worsens, does not improve, or symptoms persist for more than 7 days or clear up and reoccur again within a few days, discontinue use and consult a physician. Keep from heat.

Keep out of reach of children.

DIRECTIONS:

Apply to lips 1-3 times daily or use as directed by physician. For use on children under 5 years of age, consult a physician.

INACTIVE INGREDIENTS:

Petrolatum, Syncrowax HGL-C, Syncorwax ERL-C, Padimate-O Mineral Oil, Propylparaben, Fragrance, FD & C Yellow # 5, FD & C Blue # 1.

Package Labeling:

PETROCORT ANTIPRURITIC LIP 21 
hydrocortisone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51822-021
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE0.005 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
C18-36 ACID TRIGLYCERIDE 
PADIMATE O 
MINERAL OIL 
PROPYLPARABEN 
FD&C YELLOW NO. 5 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:51822-021-154.25 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/26/2017
Labeler - Clinical Formula LLC (084120658)
Establishment
NameAddressID/FEIOperations
Clinical Formula LLC084120658manufacture(51822-021)

 
Clinical Formula LLC

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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