FDA.reportPublic FDA data

Anti Itch Balm

Manufacturer
US ORGANIC GROUP CORP | LEORARD MOON
Effective date
2013-03-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:35:04

Label at a glance#

ProductAnti Itch Balm
Active ingredientPeppermint Oil
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Peppermint Oil* ---------- 0.34%

*=Certified Organic Ingredient

OTC - PURPOSE SECTION

Anti-Itch

INDICATIONS & USAGE SECTION

Temporarily relieves itching associated with Insect bites, Eczema, Minor burn, Sunburn, Minor skin irritations, minor cuts, scrapes, atopic dermatitis.

OTC - ASK DOCTOR SECTION

Ask a doctor if condition worsen

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

WARNINGS SECTION

- For external use only

- Do not use in or near the eyes

- Keep out of reach of children

- Ask a doctor if condition worsen

INSTRUCTIONS FOR USE SECTION

- Apply affected area and rub rapidly for 10 seconds

- Adults and children 2 years of age and older

- Children under 2 years of age: ask a doctor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of anti itchimage of anti itch

DOSAGE & ADMINISTRATION SECTION

Apply affected area and rub rapidly for 10 seconds.

INACTIVE INGREDIENT SECTION

Simmondsiachinensis (Organic Jojoba oil)*,Helianthus annuus (Organic Sunflower oil)*,Butyrospermumparkii (Organic Shea butter)*,Cera alba (Organic Bees wax)*,Calophylluminophyllum (Organic Tamanu oil)*,Oenotherabiennis (Organic Evening primerose oil)*,Rosemarinusoficinalis (Organic Rosemary) extract*,Vitamin E Oil,Lavandulaangustifolia (Organic Lavender essential oil)*,Melaleucaalternifolia (Organic Tea tree essential oil)*,Matricariarecutita (Organic Chamomile blue essential oil)*,Anthemisnobilis (Organic Chamomile roman essential oil)*,Boswelliacarterii (Organic Frankincense essential oil)*,Achilleamillefolium (Organic Yarrow blue essential oil)*
*= Certified Organic Ingredient

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1373452peppermint oil 0.34 % Topical OintmentPSN3
1373452peppermint oil 0.0034 MG/MG Topical OintmentSCD3
1373452peppermint oil 0.34 % Topical OintmentSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PEPPERMINT Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57285-100-022019-11-27C16284748780-19855d018-ed2c-cd31-e053-dbdaa90ab51aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57285-100-01Anti Itch Balm28 g in 1 JAROINTMENT283
57285-100-02Anti Itch Balm1 in 1 CARTONOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57285-100ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]3Legacy NDC, 2 package rows20130329_c0cb1412-8a46-4f41-9162-10e6f7237ef9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Peppermint OilACTIVE INGREDIENTAV092KU4JH3
PeppermintACTIVE MOIETYV95R5KMY2B3
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ13
ACHILLEA MILLEFOLIUMINACTIVE INGREDIENT2FXJ6SW4PK3
CHAMAEMELUM NOBILE FLOWER OILINACTIVE INGREDIENTUB275878393
CHAMOMILE FLOWER OILINACTIVE INGREDIENT60F80Z61A93
EVENING PRIMROSE OILINACTIVE INGREDIENT3Q9L08K71N3
FRANKINCENSE OILINACTIVE INGREDIENT67ZYA5T02K3
JOJOBA OILINACTIVE INGREDIENT724GKU717M3
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H83
ROSEMARY OILINACTIVE INGREDIENT8LGU7VM3933
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y3
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI3
TAMANU OILINACTIVE INGREDIENTJT3LVK84A13
TEA TREE OILINACTIVE INGREDIENTVIF565UC2G3
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2V3

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57285-10057285-100-01, 57285-100-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
Peppermint OilAV092KU4JHACTIB
JOJOBA OIL724GKU717MIACT
SUNFLOWER OIL3W1JG795YIIACT
SHEA BUTTERK49155WL9YIACT
YELLOW WAX2ZA36H0S2VIACT
TAMANU OILJT3LVK84A1IACT
EVENING PRIMROSE OIL3Q9L08K71NIACT
ROSEMARY OIL8LGU7VM393IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
LAVENDER OILZBP1YXW0H8IACT
TEA TREE OILVIF565UC2GIACT
CHAMOMILE FLOWER OIL60F80Z61A9IACT
CHAMAEMELUM NOBILE FLOWER OILUB27587839IACT
FRANKINCENSE OIL67ZYA5T02KIACT
ACHILLEA MILLEFOLIUM2FXJ6SW4PKIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, COATED / ORAL213.7 mgExact identifier — unii candidate
9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SYSTEM / TOPICAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, FILM COATED / ORAL246 mgExact identifier — unii candidate
10 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8GEL / TOPICAL0.1 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
SHEA BUTTERSHEA BUTTERK49155WL9YLOTION / TOPICAL2340 mgExact identifier — unii candidate
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE / ORAL44 mgExact identifier — unii candidate
9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1OINTMENT / TOPICALNAExact identifier — unii candidate
10 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8INHALANT / NASALNAExact identifier — unii candidate
2 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET / ORAL3.22 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1FILM, SOLUBLE / BUCCAL0.07 mgExact identifier — unii candidate
10 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE, EXTENDED RELEASE / ORAL80.67 mgExact identifier — unii candidate
9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.64 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
10 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCREAM / TOPICAL5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SOLUTION / ORAL1.05 mg/1mlExact identifier — unii candidate
10 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, DELAYED RELEASE / ORAL0.1 mgExact identifier — unii candidate
9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, CHEWABLE / ORAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1CAPSULE / ORAL16 mgExact identifier — unii candidate
10 equally ranked IID candidates

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
7aff6e22-67f3-408c-adcc-e2978f1c1508c0cb1412-8a46-4f41-9162-10e6f7237ef92013-03-29WarningsExact identifier
spl id: 7aff6e22-67f3-408c-adcc-e2978f1c1508
spl set id: c0cb1412-8a46-4f41-9162-10e6f7237ef9

Reported adverse events (FAERS/openFDA)#

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