Allantoin, Menthol - Aidance Skincare & Topical Solutions, LLC

Manufacturer
Aidance Skincare & Topical Solutions, LLC
Effective date
2019-01-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:12

Label at a glance#

ProductTerrasil Itch, Rash and Pain Relief Maximum Strength
Active ingredientALLANTOIN, MENTHOL
Label structure7 sections

Indications and uses

For temporary relief and protection from pain and itching associated with minor skin irritations, rashes, eczema and/or insect bites.

Dosage and administration

Apply directly to affected area. Do not use more than 4 times per day. Do not bandage damaged skin. Store at room temperature. May stain fabrics.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Allantoin 0.5%, Menthol 0.15%

Purpose

OTC - PURPOSE SECTION

Allantoin - Skin Protectant
Menthol - Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

For temporary relief and protection from pain and itching associated with minor skin irritations, rashes, eczema and/or insect bites.

Warnings

WARNINGS SECTION

For external use only. Avoid contact with eyes. Do not apply to open wounds or damaged skin. If symptoms persist for more than seven days, discontinue use and consult physician. If pregnant or breast feeding, contact physician prior to use.

Keep out of reach of children. If swallowed, consult physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

Apply directly to affected area. Do not use more than 4 times per day. Do not bandage damaged skin. Store at room temperature. May stain fabrics.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

beeswax (organic), bentonite (volcanic clay)**, cotton seed oil, eucalyptus citriodora oil, jojoba seed oil, magnesium oxide, peppermint oil, silver oxide, vegetable stearic acid (naturally sourced), zinc oxide.

**may contain this ingredient.

PRINCIPAL DISPLAY PANEL 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

All Natural
terrasil®
ITCH, RASH & PAIN RELIEF OINTMENT
MAXIMUM STRENGTH
with Activated Minerals®

TerrasilTerrasil

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1658453allantoin 0.5 % / menthol 0.15 % Topical OintmentPSN1
1658453allantoin 0.005 MG/MG / menthol 0.0015 MG/MG Topical OintmentSCD1
1658453allantoin 0.5 % / menthol 0.15 % Topical OintmentSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24909-160-14Terrasil Itch, Rash and Pain Relief Maximum Strength14 g in 1 TUBEOINTMENT141
24909-160-50Terrasil Itch, Rash and Pain Relief Maximum Strength50 g in 1 TUBEOINTMENT501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24909-160TERRASIL ITCH, RASH AND PAIN RELIEF MAXIMUM STRENGTH (ALLANTOIN, MENTHOL) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]1Legacy NDC, 2 package rows20190116_f060c699-da5a-4a93-901a-c14e1de662bc.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
24909-16024909-160-50, 24909-160-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML · Source PDF

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
ad771c96-5c3b-413c-a89f-eba2d9e44821f060c699-da5a-4a93-901a-c14e1de662bc2019-01-04WarningsExact identifier
spl id: ad771c96-5c3b-413c-a89f-eba2d9e44821
spl set id: f060c699-da5a-4a93-901a-c14e1de662bc

Reported adverse events (FAERS/openFDA)#

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