FDA.reportPublic FDA data

Moisture Barrier Cream

Manufacturer
Gentell LLC
Effective date
2026-08-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-21 02:01:39

Label at a glance#

ProductClaraVie
Active ingredientZINC OXIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 3.8% w/w

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

OTC - PURPOSE SECTION

Skin Protectant

INACTIVE INGREDIENT SECTION

Aloe Barbadendis Gel, Alpha Tocopherol, Cetomacrogol 1000, Cetostearyl Alcohol, Cetyl Alcohol, Cholecalciferol, DM Water, Glycerin, Lanolin, Lavendor, Mineral Oil, Parrafin, Phenoxyethanol, Propylene Glycol, Sodium Benzoate, Vitamin D , FD&C Yellow No.5, Microcrystalline Wax, Beeswax

WARNINGS SECTION

When using this product

  • Do not get into eyes

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 in a few days

INDICATIONS & USAGE SECTION

  • Helps treat and prevent undergarment rash
  • Temporarily protects minor cuts ,scrapes , burns , dries the oozing and weeping of poison ivy , poison oak , poison sumac

DOSAGE & ADMINISTRATION SECTION

Topical

OTC - QUESTIONS SECTION

Store at room temperature 59-86 0 F ( 15-30 0 C). Avoid excessive heat

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TestTest

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61554-30261554-302-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
.ALPHA.-TOCOPHEROL, D-N9PR3490H9IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
CHOLECALCIFEROL1C6V77QF41IACT
GLYCERINPDC6A3C0OXIACT
LANOLIN7EV65EAW6HIACT
MINERAL OILT5L8T28FGPIACT
FRAGRANCE LAVENDER ORC18009791B40MIN2W5IACT
PARAFFINI9O0E3H2ZEIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM BENZOATEOJ245FE5EUIACT
ALOE VERA LEAFZY81Z83H0XIACT
CETETH-20I835H2IHHXIACT
WATER059QF0KO0RIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
BEESWAX2ZA36H0S2VIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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
ClaraVieZINC OXIDEGentell LLC596abd98-17d7-2a22-e063-6294a90af57d2026-08-19WarningsExact identifier
ndc (package): 61554-302-11
ndc (product): 61554-302
ndc11 (package): 61554030211
spl id: 596abd98-17d8-2a22-e063-6294a90af57d
spl set id: 596abd98-17d7-2a22-e063-6294a90af57d

Reported adverse events (FAERS/openFDA)#

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