FDA.reportPublic FDA data

A&D/E Ointment

Manufacturer
Gentell LLC
Effective date
2026-08-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-21 02:02:17

Label at a glance#

ProductClaraVie
Active ingredientWHITE PETROLATUM
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum USP (93.4% w/w)

OTC - PURPOSE SECTION

Skin Protectant

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek profesional assistance or contact a Poison control Center immediately

INACTIVE INGREDIENT SECTION

Lanolin, Light Mineral Oil, Paraffin, Vitamin A, Vitamin D, Vitamin E and Cl 12740

DOSAGE & ADMINISTRATION SECTION

Apply as needed

WARNINGS SECTION

For external use only. When using this product do not get into eyes

INDICATIONS & USAGE SECTION

  • Temporarily protects minor cuts, scrapes, burns.
  • Temporarily protects and helps relieve chapped or cracked skin and lips
  • Heps protect aganist the drying effects of wind and cold weather

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TestTest

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61554-30461554-304-21

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
WHITE PETROLATUMB6E5W8RQJ4ACTIB
LIGHT MINERAL OILN6K5787QVPIACT
LANOLIN7EV65EAW6HIACT
PARAFFINI9O0E3H2ZEIACT
VITAMIN A81G40H8B0TIACT
VITAMIN D9VU1KI44GPIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
SOLVENT YELLOW 18L4SQI4K87SIACT

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
ClaraViePETROLATUMGentell LLC596987e4-4205-b911-e063-6294a90aa5702026-08-19WarningsExact identifier
ndc (package): 61554-304-21
ndc (product): 61554-304
ndc11 (package): 61554030421
spl id: 596987e4-4206-b911-e063-6294a90aa570
spl set id: 596987e4-4205-b911-e063-6294a90aa570

Reported adverse events (FAERS/openFDA)#

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