FDA.reportPublic FDA data

Barrier Balm

Manufacturer
Autumn Harp, Inc. | Autumn Harp
Effective date
2023-08-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:05:51

Label at a glance#

ProductBarrier Balm
Active ingredientDIMETHICONE 20, PETROLATUM
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Petrolatum 41.9%

Dimethicone 13.0%

OTC - PURPOSE SECTION

Helps prevent, temporarily protects and helps relieve chafed, chapped or cracked skin

Helps prevent and protect from the drying effects of wind and cold weather

Temporarily protects minor cuts, scrapes, burns

INDICATIONS & USAGE SECTION

Directions

Apply as needed

WARNINGS SECTION

Warnings

For external use only

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Do not use on deep or puncture wounds, animal bites, serious burns

When using this product do not get into eyes

Stop use and ask doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days

INACTIVE INGREDIENT SECTION

Caprylic/Capric triglyceride, Butyrospermum Parkii (Shea Butter), Aluminum Starch Octenylsuccinate, Synthetic Wax, Polyhydroxystearic Acid, Sodium Hyaluronate, Water, Zinc Oxide, Tocopheryl Acetate, Triethoxycaprylylsilane

OTC - QUESTIONS SECTION

Questions?

858-859-1188

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

DOSAGE & ADMINISTRATION SECTION

Apply as needed

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

48g tube carton artwork48g tube carton artwork15g carton artwork with drug facts box15g carton artwork with drug facts box28g carton artwork with drug facts box28g carton artwork with drug facts box15g tube primary container image15g tube primary container image28g tube primary artwork image28g tube primary artwork image48g tube primary artwork image48g tube primary artwork image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2665902dimethicone 13 % / petrolatum 41.9 % Topical OintmentPSN1
2665902dimethicone 0.13 MG/MG / petrolatum 0.419 MG/MG Topical OintmentSCD1
2665902dimethicone 13 % / petrolatum 41.9 % Topical OintmentSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51514-0363-1Barrier Balm15 g in 1 TUBEOINTMENT151
51514-0363-2Barrier Balm1 in 1 CARTONOINTMENT11
51514-0363-3Barrier Balm28 g in 1 TUBEOINTMENT281
51514-0363-4Barrier Balm1 in 1 CARTONOINTMENT11
51514-0363-5Barrier Balm48 g in 1 TUBEOINTMENT481
51514-0363-6Barrier Balm1 in 1 CARTONOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51514-0363BARRIER BALM OINTMENT [AUTUMN HARP, INC.]1Current NDC, 6 package rows20231229_01df9746-991b-4363-e063-6294a90aaac6.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51514-036351514-0363-1, 51514-0363-2, 51514-0363-3, 51514-0363-4, 51514-0363-5, 51514-0363-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ZINC OXIDESOI2LOH54ZIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
DIMETHICONE 20H8YMB5QY0DACTIB
SYNTHETIC WAX (1800 MW)248P1AUJ90IACT
WATER059QF0KO0RIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
PETROLATUM4T6H12BN9UACTIB
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SHEA BUTTERK49155WL9YIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
HYALURONATE SODIUMYSE9PPT4THIACT

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 BalmBARRIER BALMAutumn Harp, Inc.01df9746-991b-4363-e063-6294a90aaac62023-08-01WarningsExact identifier
ndc (package): 51514-0363-4
ndc (package): 51514-0363-1
ndc (package): 51514-0363-6
ndc (package): 51514-0363-5
ndc (package): 51514-0363-2
ndc (package): 51514-0363-3
ndc (product): 51514-0363
ndc11 (package): 51514036304
ndc11 (package): 51514036301
ndc11 (package): 51514036305
ndc11 (package): 51514036306
ndc11 (package): 51514036303
ndc11 (package): 51514036302
spl id: 01df9746-991c-4363-e063-6294a90aaac6
spl set id: 01df9746-991b-4363-e063-6294a90aaac6

Reported adverse events (FAERS/openFDA)#

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