FDA.reportPublic FDA data

COATS ALOE

Manufacturer
TYCHASIS CORPORATION | BIOMED LABORATORIES
Effective date
2015-10-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:44:20

Label at a glance#

ProductCOATS ALOE
Active ingredientALLANTOIN
Label structure11 sections

Indications and uses

Temporarily protects minor cuts scrapes burns Helps prevent and temporarily protects and helps relieve chaffed, chapped or cracked skin. Helps prevent and protect from the drying effects of wind and cold weather.

Dosage and administration

Apply as needed

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Allantoin 0.5%

Purpose

OTC - PURPOSE SECTION

Skin protectant.

Warnings

WARNINGS SECTION

For external use only.

When using this product do not get into eyes.

Uses:

INDICATIONS & USAGE SECTION

Temporarily protects minor

  • cuts
  • scrapes
  • burns

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

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

OTC - STOP USE SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadenesis leaf juice, water, butylene glycol, carbomer, triethanolamine, xanthum gum, panthenol, glycerin, chlorphensin, potassium sorbate, sodium benzoate, beta-glucan

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed

Use

INDICATIONS & USAGE SECTION

Apply as needed

Keep out of reach of children

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.

OTC - DO NOT USE SECTION

Do not use on deep puncture wounds, animal bits, serious burns.

COATS ALOE GELLY 8 OZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COATS ALOE GELLY 8 OZCOATS ALOE GELLY 8 OZ

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1442087allantoin 0.5 % Topical GelPSN2
1442087allantoin 0.005 MG/MG Topical GelSCD2
1442087allantoin 0.5 % Topical GelSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58826-705-082020-01-31C16284748780-19d75b9d0-d6cf-f424-e053-dadaa90a57ceCOATS ALOE GELLY 90%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58826-705-08COATS ALOE237 mL in 1 BOTTLE, DISPENSINGJELLY2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58826-705COATS ALOE (ALLANTOIN) JELLY [TYCHASIS CORPORATION]2Legacy NDC, 1 package rows20151212_20d47c70-36a2-0723-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58826-705-08ML - Milliliter58826-70571ca55c1-5136-4e84-9209-b781e95e1ee112015-10-02

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58826-70558826-705-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLORPHENESINI670DAL4SZIACT
SODIUM BENZOATEOJ245FE5EUIACT
GLYCERINPDC6A3C0OXIACT
PANTHENOLWV9CM0O67ZIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
ALLANTOIN344S277G0ZACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
BUTYLENE GLYCOL3XUS85K0RAIACT

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
21b3c8ef-774a-0045-e054-00144ff8d46c20d47c70-36a2-0723-e054-00144ff8d46c2015-10-09WarningsExact identifier
spl id: 21b3c8ef-774a-0045-e054-00144ff8d46c
spl set id: 20d47c70-36a2-0723-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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