FDA.reportPublic FDA data

Petrocort Antipruritic Lip 21

Manufacturer
Clinical Formula LLC
Effective date
2023-12-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:04:23

Label at a glance#

ProductPetrocort Antipruritic Lip 21
Active ingredientHYDROCORTISONE
Label structure6 sections

Indications and 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.

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredient (in percentage)

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 0.5%

Purpose

OTC - PURPOSE SECTION

For relief of minor skin irritation.

USES:

INDICATIONS & USAGE SECTION

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:

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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:

INACTIVE INGREDIENT SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310861hydrocortisone 0.5 % Topical OintmentPSN2
310861hydrocortisone 0.005 MG/MG Topical OintmentSCD2
310861hydrocortisone 0.5 % Topical OintmentSY2
310861hydrocortisone 5 MG per GM Topical OintmentSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROCORTISONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51822-021-15Petrocort Antipruritic Lip 214.25 g in 1 TUBELIPSTICK4.252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51822-021PETROCORT ANTIPRURITIC LIP 21 (HYDROCORTISONE) LIPSTICK [CLINICAL FORMULA LLC]2Current NDC, Legacy NDC, 1 package rows20231215_7d408e08-d777-4dfb-bb5e-b4fe5d6f4c7b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51822-02151822-021-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
C18-36 ACID TRIGLYCERIDEZRA72DR3R7IACT
PADIMATE OZ11006CMUZIACT
MINERAL OILT5L8T28FGPIACT
PROPYLPARABENZ8IX2SC1OHIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
HYDROCORTISONEWI4X0X7BPJACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Petrocort Antipruritic Lip 21HYDROCORTISONEClinical Formula LLC7d408e08-d777-4dfb-bb5e-b4fe5d6f4c7b2023-12-15WarningsExact identifier
ndc (package): 51822-021-15
ndc (product): 51822-021
ndc11 (package): 51822002115
spl id: 0c863e4e-1b19-6315-e063-6294a90a9034
spl set id: 7d408e08-d777-4dfb-bb5e-b4fe5d6f4c7b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.