FDA.reportPublic FDA data

Lantiseptic by Dermarite Dry Skin Therapy

Manufacturer
Dermarite Industries LLC
Effective date
2024-12-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:40:56

Label at a glance#

ProductLantiseptic by Dermarite Dry Skin Therapy
Active ingredientLANOLIN
Label structure8 sections

Indications and uses

Temporarily protects minor cuts, scrapes, and burns. Helps prevent and temporarily protects chafed, chapped or cracked skin.

Dosage and administration

Apply liberally to affected area as needed or as directed by a physician.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lanolin USP 30%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects minor cuts, scrapes, and burns.

Helps prevent and temporarily protects chafed, chapped or cracked skin.

Warnings

WARNINGS SECTION

• For external use only.

• Avoid contact with eyes. In case of contact, flush thoroughly with water

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

Stop use and ask a doctor if

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

Keep our of reach of children. In case of accidental ingestion contact a physician or Poision Control Center right away.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally to affected area as needed or as directed by a physician.

Other Information

SPL UNCLASSIFIED SECTION

Store at room temperature (59-86°F)

You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Mineral Oil, Petrolatum, Cera Alba, Sodium Borate, DMDM Hydantoin, Sorbitan Sesquioleate, Lanolin Alcohol, Disodium EDTA.

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-800-337-6296 Mon-Fri 9AM-5PM EST

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

principal display panelprincipal display panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1657183lanolin 30 % Topical CreamPSN3
1657185Lantiseptic 30 % Topical CreamPSN3
1657185lanolin 300 MG/ML Topical Cream [Lantiseptic]SBD3
1657183lanolin 300 MG/ML Topical CreamSCD3
1657183lanolin 30 % Topical CreamSY3
1657185Lantiseptic 30 % Topical CreamSY3
1657185Lantiseptic 300 MG/ML Topical CreamSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61924-504-042026-01-29C16284748780-1d6a99b39-d382-a426-e053-dadaa90af4c2Lantiseptic by Dermarite Dry Skin Therapy
61924-504-052026-01-29C16284748780-1d6a99b39-d382-a426-e053-dadaa90af4c2Lantiseptic by Dermarite Dry Skin Therapy
61924-504-142026-01-29C16284748780-1d6a99b39-d382-a426-e053-dadaa90af4c2Lantiseptic by Dermarite Dry Skin Therapy
61924-504-042024-12-06C16284748780-1d6a99b39-d382-a426-e053-dadaa90af4c2Lantiseptic by Dermarite Dry Skin Therapy
61924-504-052024-12-06C16284748780-1d6a99b39-d382-a426-e053-dadaa90af4c2Lantiseptic by Dermarite Dry Skin Therapy
61924-504-142024-12-06C16284748780-1d6a99b39-d382-a426-e053-dadaa90af4c2Lantiseptic by Dermarite Dry Skin Therapy
61924-504-042022-01-28C16284748780-1d6a99b39-d382-a426-e053-dadaa90af4c2Lantiseptic by Dermarite Dry Skin Therapy
61924-504-052022-01-28C16284748780-1d6a99b39-d382-a426-e053-dadaa90af4c2Lantiseptic by Dermarite Dry Skin Therapy
61924-504-142022-01-28C16284748780-1d6a99b39-d382-a426-e053-dadaa90af4c2Lantiseptic by Dermarite Dry Skin Therapy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61924-504-04Lantiseptic by Dermarite Dry Skin Therapy113 g in 1 TUBECREAM1133
61924-504-05Lantiseptic by Dermarite Dry Skin Therapy5 g in 1 PACKETCREAM53
61924-504-14Lantiseptic by Dermarite Dry Skin Therapy14.2 g in 1 PACKETCREAM14.23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61924-504LANTISEPTIC BY DERMARITE DRY SKIN THERAPY (LANOLIN) CREAM [DERMARITE INDUSTRIES LLC]3Legacy NDC, 3 package rows20241208_7730af3b-fea2-63ee-e053-2991aa0afe0c.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61924-50461924-504-14, 61924-504-04, 61924-504-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
YELLOW WAX2ZA36H0S2VIACT
CAPRYLYL GLYCOL00YIU5438UIACT
EDETATE DISODIUM7FLD91C86KIACT
LANOLIN ALCOHOLS884C3FA9HEIACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
WATER059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
LANOLIN7EV65EAW6HACTIB

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
288a1e26-e682-3929-e063-6394a90a33b97730af3b-fea2-63ee-e053-2991aa0afe0c2024-12-05WarningsExact identifier
spl id: 288a1e26-e682-3929-e063-6394a90a33b9
spl set id: 7730af3b-fea2-63ee-e053-2991aa0afe0c

Reported adverse events (FAERS/openFDA)#

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