COATS ALOE LOTION

Manufacturer
TYCHASIS CORPORATION | BIOMED LABORATORIES
Effective date
2024-10-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:30:51

Label at a glance#

ProductCOATS ALOE
Active ingredientALLANTOIN
Label structure11 sections

Indications and uses

Temporarily protects minor: cuts scapes 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.

Do not get into eyes.

Stop use if:

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.

Uses:

INDICATIONS & USAGE SECTION

Temporarily protects minor:

  • cuts
  • scapes
  • 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.

Caution:

OTC - DO NOT USE SECTION

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

Keep out of reach of children:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a poison control center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply as needed.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

aloe barbanesis leaf juice, ethylhexyl palmitate, glycerin, methylgluceth-20, glyceryl stearate, C12-15 alkyl benzoate, water, cetyl alcohol, triethanolomine, stearic acid, ethylhexyl stearate, diethylhexyl adipate, retinyl palmitate, tocopheryl acetate, laureth-4, laureth-23, carbomer, diazolidinyl urea, methylparaben, propylparaben

Questions:

OTC - QUESTIONS SECTION

Toll free 888-650-0040

Package label COATS ALOE LOTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COATS ALOE LOTION 8 OZCOATS ALOE LOTION 8 OZ

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1087954allantoin 0.5 % Topical LotionPSN4
1087954allantoin 5 MG/ML Topical LotionSCD4
1087954allantoin 0.5 % Topical LotionSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70211-702-022026-01-29C16284748780-149896155-a478-586f-e063-e6dba90add90COATS ALOE LOTION
70211-702-082026-01-29C16284748780-149896155-a478-586f-e063-e6dba90add90COATS ALOE LOTION
70211-702-332026-01-29C16284748780-149896155-a478-586f-e063-e6dba90add90COATS ALOE LOTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70211-702-02COATS ALOE59 mL in 1 BOTTLE, DISPENSINGLOTION594
70211-702-08COATS ALOE237 mL in 1 BOTTLE, DISPENSINGLOTION2374
70211-702-33COATS ALOE976 mL in 1 BOTTLE, DISPENSINGLOTION9764

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70211-702COATS ALOE (ALLANTOIN) LOTION [TYCHASIS CORPORATION]4Legacy NDC, 3 package rows20241030_23939910-3d59-5ffb-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70211-702-02ML - Milliliter70211-70297513aff-3dbe-4b56-a255-e51ad2ee581212016-02-04
70211-702-08ML - Milliliter70211-702258de705-e53b-42fd-b96b-8fa5cff0c24a12016-02-04
70211-702-33ML - Milliliter70211-7022cfa267e-2bef-40be-b20a-7cceb812f26012016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALLANTOINACTIVE INGREDIENT344S277G0Z1
ALLANTOINACTIVE MOIETY344S277G0Z1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
BOROGLYCERININACTIVE INGREDIENTU3LMU4AN211
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW41
DIETHYLHEXYL ADIPATEINACTIVE INGREDIENTMBY1SL921L1
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT28659933091
ETHYLHEXYL STEARATEINACTIVE INGREDIENTEG3PA2K3K51
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785I1
LAURETH-23INACTIVE INGREDIENTN72LMW566G1
LAURETH-4INACTIVE INGREDIENT6HQ855798J1
METHYL GLUCETH-20INACTIVE INGREDIENTJ3QD0LD11P1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P81
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70211-70270211-702-02, 70211-702-08, 70211-702-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

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 4 · 213 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / PARENTERAL30 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii candidate
79 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii candidate
26 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLIQUID / ORAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
LAURETH-4LAURETH-46HQ855798JGEL / TOPICAL60 mgExact identifier — unii candidate
4 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION/ DROPS / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, EXTENDED RELEASE / ORAL132 mgExact identifier — unii candidate
20 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSOLUTION / TOPICALNAExact identifier — unii candidate
20 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SUSPENSION / SUBCUTANEOUS0.16 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SUSPENSION / INTRAMUSCULAR1 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / VAGINAL3 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHPOWDER / ORALNAExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRALESIONAL0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPOWDER, FOR SUSPENSION / ORAL75 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / RECTAL1808 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / TOPICAL216 mgExact identifier — unii candidate
79 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / VAGINAL0.75 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / TOPICAL82 mgExact identifier — unii candidate
20 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / SOFT TISSUE0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii candidate
26 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHPOWDER, FOR SOLUTION / ORAL13 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii candidate
68 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii candidate
20 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSHAMPOO / TOPICAL0.03 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERYL STEARATE SEGLYCERYL STEARATE SEFCZ5MH785ICREAM / TOPICAL4 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRA-ARTICULAR0.03 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / VAGINAL22 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
79 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE, COATED / ORAL0.25 mgExact identifier — unii candidate
5 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APIMPLANT / SUBCUTANEOUS1.04 mgExact identifier — unii candidate
26 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNOINTMENT / TOPICAL7 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLOTION / TOPICAL140 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TEMULSION / TOPICAL0.2 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / AURICULAR (OTIC)1 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET / ORAL1.8 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TFILM / BUCCAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHGEL / VAGINAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHENEMA / RECTAL0.02 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSPRAY / NASAL0.2 mgExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERYL STEARATE SEGLYCERYL STEARATE SEFCZ5MH785ILOTION / TOPICAL46 mgExact identifier — unii candidate
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCAPSULE, DELAYED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APPOWDER, FOR SUSPENSION / ORAL1203 mg/5mlExact identifier — unii candidate
26 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TENEMA / RECTAL0.18 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHEMULSION / TOPICAL0.06 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
68 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, FILM COATED / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / OPHTHALMIC0.02 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / PARENTERAL18 mgExact identifier — unii candidate
79 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8INJECTION, EMULSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
5 equally ranked IID candidates
LAURETH-23LAURETH-23N72LMW566GAEROSOL / TOPICAL0.45 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHFILM / BUCCAL0.22 mgExact identifier — unii candidate
68 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii candidate
20 equally ranked IID candidates
LAURETH-23LAURETH-23N72LMW566GAEROSOL, FOAM / TOPICAL1.08 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSHAMPOO / TOPICAL0.15 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR0.4 mgExact identifier — unii candidate
68 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
2589f0da-052d-a6e0-e063-6294a90aaccf23939910-3d59-5ffb-e054-00144ff8d46c2024-10-28WarningsExact identifier
spl id: 2589f0da-052d-a6e0-e063-6294a90aaccf
spl set id: 23939910-3d59-5ffb-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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