FDA.reportPublic FDA data

Dry Skin Protectant

Manufacturer
Gentell LLC
Effective date
2026-08-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-22 01:01:04

Label at a glance#

ProductClaravie
Active ingredientLANOLIN
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION


Lanolin 30%

OTC - PURPOSE SECTION

Skin Protectant

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


In case of accidental ingestion, contact a physician or Poison Control Center right away.

WARNINGS SECTION

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 within a few days

Do not use on

deep or puncture wounds
animal bites
serious burns

OTC - ASK DOCTOR SECTION

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

INDICATIONS & USAGE SECTION

Uses

Temporarily protects minor:

cuts
scrapes
burns

Temporarily protects and helps relieve chafed, chapped or cracked skin
Helps protect from the drying effects of wind and cold weather.

Directions

Apply as needed

OTC - QUESTIONS SECTION

Dry Skin Protectant 4oz_TubeDry Skin Protectant 4oz_TubeDry Skin Protectant 5g_Sachet

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, contact a physician or Poison control center right away.

DOSAGE & ADMINISTRATION SECTION

Apply as needed

INACTIVE INGREDIENT SECTION

Petrolatum, Mineral Oil, Water, Sorbiton Sesquioleate, Beeswax, Disodium EDTA, Lanolin Alcohol, Sodium Borate, Phenoxyethanol, Ethylglycerin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
61554-30161554-301-11, 61554-301-21

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
LANOLIN7EV65EAW6HACTIB
PETROLATUM4T6H12BN9UIACT
MINERAL OILT5L8T28FGPIACT
WATER059QF0KO0RIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
BEESWAX2ZA36H0S2VIACT
EDETATE DISODIUM7FLD91C86KIACT
LANOLIN ALCOHOL884C3FA9HEIACT
SODIUM BORATE91MBZ8H3QOIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
ClaravieLANOLINGentell LLC596c1b73-e34d-c97d-e063-6394a90ada1b2026-08-19WarningsExact identifier
ndc (package): 61554-301-21
ndc (package): 61554-301-11
ndc (product): 61554-301
ndc11 (package): 61554030111
ndc11 (package): 61554030121
spl id: 596c1b73-e34e-c97d-e063-6394a90ada1b
spl set id: 596c1b73-e34d-c97d-e063-6394a90ada1b

Reported adverse events (FAERS/openFDA)#

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