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 22:43:52

Label at a glance#

ProductCOATS ALOE

Active ingredientALLANTOIN

Label structure11 sections

Indications and uses

Skin protectant

Dosage and administration

Apply as needed.

Contacts and useful links#

PhoneLabel contact888-650-0040

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Allantoin 0.5%

Uses:

OTC - PURPOSE SECTION

Skin protectant

Warnings

WARNINGS SECTION

For external use only.

Do not get into eyes.

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
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.

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.

Directions:

INDICATIONS & USAGE SECTION

Apply as needed.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

water, aloe barbadensis leaf juice, caprylic/-capric triglyceride, cetyl alcohol, postassium palmitoyl hydrolyzed wheat protein, glycerol stearate, pentylene glycol, butyrospermum parkii (shea) butter, c12-15 alkyl benzoate, glycerin, beta-glucan, sodium hyaluronate, glyceryl stearate SE, cetearath-20, dehydroacetic acid, benzyl alcohol

Questions:

OTC - QUESTIONS SECTION

Toll free number 888-650-0040

Package Label: COATS ALOE CREME 4 OZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COATSALOECREME4OZ

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
241509	allantoin 0.5 % Topical Cream	PSN	2
241509	allantoin 5 MG/ML Topical Cream	SCD	2
241509	allantoin 0.5 % Topical Cream	SY	2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58826-703-04	2020-01-31	C162847	48780-1	9d75b9cf-f6e0-f424-e053-dadaa90a57ce	COATS ALOE CREME
58826-703-16	2020-01-31	C162847	48780-1	9d75b9cf-f6e0-f424-e053-dadaa90a57ce	COATS ALOE CREME

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58826-703-04	COATS ALOE	118 g in 1 JAR	CREAM	118		2
58826-703-16	COATS ALOE	454 g in 1 JAR	CREAM	454		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58826-703	COATS ALOE (ALLANTOIN) CREAM [TYCHASIS CORPORATION]	2	Legacy NDC, 2 package rows	20151019_20d1606d-fdb5-5ce8-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58826-703-04	GM - Gram	58826-703	5e9b6354-7ea5-4647-96b7-8ed19d6adb63	1	2015-10-02
58826-703-16	GM - Gram	58826-703	3a9ecb83-dcb4-4825-90e8-ddb25604833e	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ALLANTOIN	ACTIVE INGREDIENT	344S277G0Z	2
ALLANTOIN	ACTIVE MOIETY	344S277G0Z	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	2
C12-15 ALKYL BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	2
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE	INACTIVE INGREDIENT	FJ1H6M2JG9	2
DEHYDROACETIC ACID	INACTIVE INGREDIENT	2KAG279R6R	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
GLYCERYL STEARATE SE	INACTIVE INGREDIENT	FCZ5MH785I	2
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	2
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW)	INACTIVE INGREDIENT	J2S07SB0YL	2
PENTYLENE GLYCOL	INACTIVE INGREDIENT	50C1307PZG	2
POTASSIUM PALMITATE	INACTIVE INGREDIENT	KTC40CLC68	2
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

COATS ALOE
ALLANTOIN
ALOE VERA LEAF
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE
PENTYLENE GLYCOL
WATER
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW)
POTASSIUM PALMITATE
GLYCERYL STEARATE SE
SHEA BUTTER
C12-15 ALKYL BENZOATE
GLYCERIN
HYALURONATE SODIUM
DEHYDROACETIC ACID
BENZYL ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58826-703	58826-703-04, 58826-703-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALOE VERA LEAF	ZY81Z83H0X	IACT
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE	FJ1H6M2JG9	IACT
PENTYLENE GLYCOL	50C1307PZG	IACT
WATER	059QF0KO0R	IACT
ALLANTOIN	344S277G0Z	ACTIB
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW)	J2S07SB0YL	IACT
POTASSIUM PALMITATE	KTC40CLC68	IACT
GLYCERYL STEARATE SE	FCZ5MH785I	IACT
SHEA BUTTER	K49155WL9Y	IACT
C12-15 ALKYL BENZOATE	A9EJ3J61HQ	IACT
GLYCERIN	PDC6A3C0OX	IACT
HYALURONATE SODIUM	YSE9PPT4TH	IACT
DEHYDROACETIC ACID	2KAG279R6R	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT

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 3 · 135 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / SUBCONJUNCTIVAL		252 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	CAPSULE, EXTENDED RELEASE / ORAL	1.23 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DROPS / ORAL	300 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	CREAM / VAGINAL	1 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, EMULSION / INTRAVENOUS		45 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SUSPENSION / SUBCUTANEOUS	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	8.4 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
DEHYDROACETIC ACID	DEHYDROACETIC ACID	2KAG279R6R	LOTION / TOPICAL		1 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / VAGINAL		60 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SUPPOSITORY / RECTAL	129 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	CAPSULE / ORAL		450 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	LIQUID / INTRAVENOUS	1.04 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
HYALURONATE SODIUM	HYALURONATE SODIUM	YSE9PPT4TH	INJECTION, SUSPENSION / INTRAMUSCULAR		23 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
SHEA BUTTER	SHEA BUTTER	K49155WL9Y	LOTION / TOPICAL		2340 mg	Exact identifier — unii candidate
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL		32400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS		18 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / TOPICAL		18144 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / SUBCUTANEOUS		90 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	GEL / RECTAL		124 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SHAMPOO / TOPICAL	1.25 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SOLUTION / SUBCUTANEOUS	0.95 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	TABLET, DELAYED RELEASE / ORAL	2.31 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRACAVITARY	0.01 ml		Exact identifier — unii candidate 50 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / INTRAMUSCULAR		40 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
GLYCERYL STEARATE SE	GLYCERYL STEARATE SE	FCZ5MH785I	LOTION / TOPICAL		46 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL		3487 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
HYALURONATE SODIUM	HYALURONATE SODIUM	YSE9PPT4TH	LOTION / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
HYALURONATE SODIUM	HYALURONATE SODIUM	YSE9PPT4TH	INJECTION, SUSPENSION / INTRAVITREAL		23 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / OPHTHALMIC		58 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	GEL / TOPICAL		185 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / OPHTHALMIC		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / INTRAVENOUS	2.2 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	MOUTHWASH / BUCCAL	100 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY, METERED / NASAL		13 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SHAMPOO / TOPICAL	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SOLUTION / INTRAMUSCULAR		500 mg	Exact identifier — unii candidate 50 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
21b3c8ef-7748-0045-e054-00144ff8d46c			20d1606d-fdb5-5ce8-e054-00144ff8d46c	2015-10-09	Warnings	Exact identifier spl id: 21b3c8ef-7748-0045-e054-00144ff8d46c spl set id: 20d1606d-fdb5-5ce8-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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