FDA.reportPublic FDA data

Advanced Barrier Cream

Manufacturer
Gentell LLC
Effective date
2026-08-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-25 01:01:56

Label at a glance#

ProductClaravie
Active ingredientZINC OXIDE, DIMETHICONE
Label structure14 sections

Indications and uses

Helps prevent and protect protective undergarment rash. Protects minor skin irritation associated with protective undergarment rash and helps seal out wetness.

Dosage and administration

Change wet and soiled protective undergarments promptly. Cleanse the protective undergarment area, and allow to dry. Apply cream liberally as often as necessary with each protective undergarment change, especially at bedtime or anytime when exposure to wet protective undergarments may be prolonged.

Storage and handling

Store between 59°F–86°F (15°C–30°C)

Label contents#

Full prescribing information#

DESCRIPTION SECTION

“Powered by nature, perfected by science—the ClaraVie™ skin care collection offers a harmonious blend of advanced technology and natural ingredients for radiant, healthy skin.”

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 12% w/w
Dimethicone 1% w/w

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent and protect protective undergarment rash.
  • Protects minor skin irritation associated with protective undergarment 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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

INSTRUCTIONS FOR USE SECTION

  • Change wet and soiled protective undergarments promptly.
  • Cleanse the protective undergarment area, and allow to dry.
  • Apply cream liberally as often as necessary with each protective undergarment change, especially at bedtime or anytime when exposure to wet protective undergarments may be prolonged.

Other Information

STORAGE AND HANDLING SECTION

  • Store between 59°F–86°F (15°C–30°C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Aluminum Stearate, Beeswax, Chloroxylenol, Cholecalciferol, Corn Oil, Ethylhexylglycerin, Fragrance, Imidazolidinyl Urea, Lanolin, Mineral Oil, Paraffin, Petrolatum, Phenoxyethanol, Propylene Glycol, Sorbitan Sesquioleate, Tocopherol Acetate, Vitamin A Palmitate, Water

DOSAGE & ADMINISTRATION SECTION

Apply cream liberally as often as necessary with each protective undergarment change, especially at bedtime or anytime when exposure to wet protective undergarments may be prolonged.

Advanced Barrier Cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advance barrier Cream Label:

AB CreamAB Cream

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61554-31261554-312-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
DIMETHICONE92RU3N3Y1OACTIB
ALOE BARBADENSIS LEAFZY81Z83H0XIACT
ALUMINUM STEARATEU6XF9NP8HMIACT
BEESWAX2ZA36H0S2VIACT
CHLOROXYLENOL0F32U78V2QIACT
CHOLECALCIFEROL1C6V77QF41IACT
CORN OIL8470G57WFMIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
IMIDAZOLIDINYL UREAM629807ATLIACT
LANOLIN7EV65EAW6HIACT
MINERAL OILT5L8T28FGPIACT
PARAFFINI9O0E3H2ZEIACT
PETROLATUM4T6H12BN9UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
WATER059QF0KO0RIACT

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 OXIDE, DIMETHICONEGentell LLC598a5c0b-1e2f-1335-e063-6394a90ac4f42026-08-21WarningsExact identifier
ndc (package): 61554-312-11
ndc (product): 61554-312
ndc11 (package): 61554031211
spl id: 598a5c0b-1e30-1335-e063-6394a90ac4f4
spl set id: 598a5c0b-1e2f-1335-e063-6394a90ac4f4

Reported adverse events (FAERS/openFDA)#

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