FDA.reportPublic FDA data

Hania Skin Protectant

Manufacturer
Natureplex LLC
Effective date
2025-02-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:55:42

Label at a glance#

ProductHania Skin Protectant
Active ingredientPetrolatum
Label structure10 sections

Indications and uses

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

Dosage and administration

for skin protectant: Apply as needed for diaper rash: change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry apply the ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Storage and handling

do not use if seal is broken

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 98 %

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Centre right away: 800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

  • for skin protectant: Apply as needed
  • for diaper rash:
    • change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry
    • apply the ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other information

STORAGE AND HANDLING SECTION

  • do not use if seal is broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

Figwort, Plantain, Gota Kola, Pau D'arco, Yarrow

Questions or comments?

OTC - QUESTIONS SECTION

Call us at 866-323-0107 or www.natureplex.com

PRINCIPAL DISPLAY PANEL - 100 ml Jar Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HANIA™

SKIN PROTECTANT

Protects minor cuts, scrapes and burns

Restores and soothes dry, chapped and chafed skin

Enriched with natural ingredients

FRAGRANCE FREE
FRAGRANCE FREE

PRESERVATIVES FREE
PRESERVATIVES FREE

NET VOL. 3.38 fl oz (100ml)

PRINCIPAL DISPLAY PANEL - 100 ml Jar Label
PRINCIPAL DISPLAY PANEL - 100 ml Jar Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2705552petrolatum 98 % Topical OintmentPSN2
2705552petrolatum 0.98 MG/MG Topical OintmentSCD2
2705552petrolatum 98 % Topical OintmentSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67234-082-01Hania Skin Protectant100 mL in 1 JAROINTMENT1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67234-082HANIA SKIN PROTECTANT (PETROLATUM) OINTMENT [NATUREPLEX LLC]2Current NDC, 1 package rows20250223_63609a57-91fc-4cfd-b942-b69a0d2fb284.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67234-08267234-082-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
Petrolatum4T6H12BN9UACTIB
SCROPHULARIA NODOSA ROOT3R84T369J0IACT
MUSA X PARADISIACA WHOLEI4U55R240NIACT
CENTELLA ASIATICA WHOLE7M867G6T1UIACT
HANDROANTHUS IMPETIGINOSUS WHOLED65QWF3541IACT
ACHILLEA MILLEFOLIUM WHOLE2FXJ6SW4PKIACT

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
Hania Skin ProtectantPETROLATUMNatureplex LLC63609a57-91fc-4cfd-b942-b69a0d2fb2842025-02-19WarningsExact identifier
ndc (package): 67234-082-01
ndc (product): 67234-082
ndc11 (package): 67234008201
spl id: 43c7e6c7-ef61-4cca-b31d-a74eaf663d36
spl set id: 63609a57-91fc-4cfd-b942-b69a0d2fb284

Reported adverse events (FAERS/openFDA)#

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