FDA.reportPublic FDA data

Barrier Cream

Manufacturer
Avasol LLC
Effective date
2023-05-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:35:06

Label at a glance#

ProductBarrier Cream
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

Temporarily protects the skin and prevents chafing, blisters and irritation and helps seal out wetness. Helps prevent and helps relieve minor skin irritation and itching due to rashes, chafed, chapped, cracked, or windburned skin.

Dosage and administration

Apply liberally, directly on skin as needed. Safe to apply to prosthetics, protective equipment, etc.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (Non-nano) 10%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • Temporarily protects the skin and prevents chafing, blisters and irritation and helps seal out wetness.
  • Helps prevent and helps relieve minor skin irritation and itching due to rashes, chafed, chapped, cracked, or windburned skin.

Warnings

WARNINGS SECTION

  • For external use only
  • Avoid contact with eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

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

OTC - DO NOT USE SECTION

Do not use:

  • if allergic to ingredients.
  • on deep or puncture wounds
  • on animal bites •on serious burns.
  • Test small area first.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally, directly on skin as needed. Safe to apply to prosthetics, protective equipment, etc.

RECENT MAJOR CHANGES SECTION

Inactive ingredients

INACTIVE INGREDIENT SECTION

*Caprylic/Capric Triglyceride (Fractionated Coconut Oil), *Cocos Nucifera (Coconut) Oil, *Cera Alba (beeswax), **Euphorbia Cerifera (candelilla) wax, *Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol, Olea Europaea (Olive) Leaf Extract, Citrus Aurantium Dulcis Peel Cera, Astaxanthin, Bentonite, Cetearyl Olivate, Sorbitan Olivate, *Propolis, *Lavandula Angustifolia (Lavender) Oil, *Rosmarinus Officinalis (Rosemary) Leaf Extract,*Aloe barbadensis,*St. John's wort (Hypericum perforatum),*Chamomile (Matricaria chamomilla L), *Licorice Root (Glycyrrhiza glabra), *Calendula Officinalis Flower Extract, **Leptospermum scoparium (Manuka) Oil, *Mentha Piperita (Peppermint) Oil *Organic

Other information

OTHER SAFETY INFORMATION

store product between 45 to 100F

Gently warm or knead product as needed to soften before use.

Questions?

OTC - QUESTIONS SECTION

Call 888-805-1507 or visit www.avasol.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Avasol Barrier CreamAvasol Barrier Cream

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58518-040-022026-01-27C16284748780-1f386c649-d375-0266-e053-dadaa90a7c1aBarrier Cream
58518-040-032026-01-27C16284748780-1f386c649-d375-0266-e053-dadaa90a7c1aBarrier Cream
58518-040-022025-01-30C16284748780-1f386c649-d375-0266-e053-dadaa90a7c1aBarrier Cream
58518-040-032025-01-30C16284748780-1f386c649-d375-0266-e053-dadaa90a7c1aBarrier Cream
58518-040-022023-04-24C16284748780-1f386c649-d375-0266-e053-dadaa90a7c1aBarrier Cream
58518-040-032023-04-24C16284748780-1f386c649-d375-0266-e053-dadaa90a7c1aBarrier Cream
58518-040-022023-01-30C16284748780-1f386c649-d375-0266-e053-dadaa90a7c1aBarrier Cream
58518-040-032023-01-30C16284748780-1f386c649-d375-0266-e053-dadaa90a7c1aBarrier Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58518-040-02Barrier Cream59 mL in 1 POUCHCREAM593
58518-040-03Barrier Cream28 mL in 1 TUBECREAM283

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58518-04058518-040-02, 58518-040-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
COCONUT OILQ9L0O73W7LIACT
YELLOW WAX2ZA36H0S2VIACT
CANDELILLA WAXWL0328HX19IACT
JOJOBA OIL724GKU717MIACT
TOCOPHEROLR0ZB2556P8IACT
OLEA EUROPAEA LEAFMJ95C3OH47IACT
ORANGE PEEL WAX0U715N387CIACT
ASTAXANTHIN8XPW32PR7IIACT
BENTONITEA3N5ZCN45CIACT
CETEARYL OLIVATE58B69Q84JOIACT
SORBITAN OLIVATEMDL271E3GRIACT
PROPOLIS WAX6Y8XYV2NOFIACT
LAVENDER OILZBP1YXW0H8IACT
ROSEMARYIJ67X351P9IACT
ALOE VERA WHOLEKIZ4X2EHYXIACT
ST. JOHN'S WORTUFH8805FKAIACT
CHAMOMILEFGL3685T2XIACT
LICORICE61ZBX54883IACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
MANUKA OILM6QU9ZUH2XIACT
PEPPERMINT OILAV092KU4JHIACT
ZINC OXIDESOI2LOH54ZACTIB

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
Barrier CreamZINC OXIDEAvasol LLCbc6a2736-faa6-46d3-af9b-a70f0762e9ce2023-05-15WarningsExact identifier
ndc (package): 58518-040-03
ndc (package): 58518-040-02
ndc (product): 58518-040
ndc11 (package): 58518004002
ndc11 (package): 58518004003
spl id: fbc1e407-09f5-1d83-e053-6294a90aef0f
spl set id: bc6a2736-faa6-46d3-af9b-a70f0762e9ce

Reported adverse events (FAERS/openFDA)#

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