Fruit of the Earth Aloe Vera Cool Blue Gel

Manufacturer: Fruit of the Earth, Inc.
Effective date: 2024-07-19
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 00:15:56

Label at a glance#

ProductFruit of the Earth Aloe Vera Cool Blue

Active ingredientLIDOCAINE

Label structure12 sections

Indications and uses

For the temporary relief of pain and itching associated with sunburn, minor burns, minor cuts, scrapes, insect bites, and minor skin irritations.

Dosage and administration

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily Children under 2 years of age: Ask a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 1.0% (as Lidocaine HCl)

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching associated with sunburn, minor burns, minor cuts, scrapes, insect bites, and minor skin irritations.

Warnings

WARNINGS SECTION

For External Use Only

OTC - DO NOT USE SECTION

Do not usein large quantities, particularly over raw surfaces or blistered areas

OTC - WHEN USING SECTION

When using this productavoid contact with eyes. If contact occurs, rinse with water to remove.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if

condition worsens
symptoms persist for more than 7 days
symptoms clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, seek medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older:Apply to affected area not more than 3 to 4 times daily
Children under 2 years of age:Ask a doctor.

OTHER SAFETY INFORMATION

Other Information:May stain some fabrics.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Isoceteth-20, Triethanolamine, Carbomer, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Benzophenone-4, Blue 1.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fruit of the Earth

Aloe Vera

Cool Blue Gel

567 grams

NDC: 62217-200-20

Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1012204	lidocaine HCl 1 % Topical Gel	PSN	4
1012204	lidocaine hydrochloride 0.01 MG/MG Topical Gel	SCD	4
1012204	lidocaine hydrochloride 1 % Topical Gel	SY	4

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
LIDOCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62217-200-20	Fruit of the Earth Aloe Vera Cool Blue	567 g in 1 BOTTLE	GEL	567		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62217-200	FRUIT OF THE EARTH ALOE VERA COOL BLUE (LIDOCAINE HYDROCHLORIDE) GEL [FRUIT OF THE EARTH, INC.]	4	Current NDC, Legacy NDC, 1 package rows	20240725_1d65bc34-2bc2-4f52-a9b3-1cb08324eb79.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
LIDOCAINE	ACTIVE INGREDIENT	98PI200987	2
LIDOCAINE	ACTIVE MOIETY	98PI200987	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	2
CARBOMER 940	INACTIVE INGREDIENT	4Q93RCW27E	2
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	2
ISOCETETH-20	INACTIVE INGREDIENT	O020065R7Z	2
MAGNESIUM NITRATE	INACTIVE INGREDIENT	77CBG3UN78	2
MAGNESIUM SULFATE	INACTIVE INGREDIENT	DE08037SAB	2
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	2
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	2
SULISOBENZONE	INACTIVE INGREDIENT	1W6L629B4K	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	2

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Fruit of the Earth Aloe Vera Cool Blue
Lidocaine Hydrochloride
ALOE VERA LEAF
ISOCETETH-20
TROLAMINE
CARBOMER HOMOPOLYMER TYPE C
EDETATE SODIUM
FD&C BLUE NO. 1
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
SULISOBENZONE
LIDOCAINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62217-200	62217-200-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALOE VERA LEAF	ZY81Z83H0X	IACT
ISOCETETH-20	O020065R7Z	IACT
TROLAMINE	9O3K93S3TK	IACT
CARBOMER HOMOPOLYMER TYPE C	4Q93RCW27E	IACT
EDETATE SODIUM	MP1J8420LU	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
METHYLCHLOROISOTHIAZOLINONE	DEL7T5QRPN	IACT
METHYLISOTHIAZOLINONE	229D0E1QFA	IACT
SULISOBENZONE	1W6L629B4K	IACT
LIDOCAINE	98PI200987	ACTIB

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 · 28 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	LOTION / TOPICAL	0.17 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CREAM / TOPICAL	0.01 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
MAGNESIUM SULFATE	MAGNESIUM SULFATE	DE08037SAB	SOAP / TOPICAL	0.2 %w/w		Exact identifier — unii+route 2 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SPONGE / TOPICAL	0.14 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
CARBOMER 940	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL / TOPICAL		85 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOAP / TOPICAL	0.01 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / TOPICAL	NA		Exact identifier — unii+route 12 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	LOTION / TOPICAL	0.17 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
CARBOMER 940	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL / TOPICAL		85 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MAGNESIUM SULFATE	MAGNESIUM SULFATE	DE08037SAB	SOAP / TOPICAL	0.2 %w/w		Exact identifier — unii+route 2 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CREAM / TOPICAL	0.01 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LOTION / TOPICAL	NA		Exact identifier — unii+route 12 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SPONGE / TOPICAL	0.14 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SHAMPOO / TOPICAL	0.75 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / TOPICAL	NA		Exact identifier — unii+route 12 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SHAMPOO / TOPICAL	1.33 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / TOPICAL	0.01 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SHAMPOO / TOPICAL	0.75 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LOTION / TOPICAL	NA		Exact identifier — unii+route 12 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SOLUTION / TOPICAL	0.3 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SOLUTION / TOPICAL	0.3 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / TOPICAL	0.01 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SOAP / TOPICAL	0.12 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SOAP / TOPICAL	0.12 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SHAMPOO / TOPICAL	1.33 %w/w		Exact identifier — unii+route 10 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOAP / TOPICAL	0.01 %w/w		Exact identifier — unii+route 12 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
Fruit of the Earth Aloe Vera Cool Blue	LIDOCAINE HYDROCHLORIDE	Fruit of the Earth, Inc.	1d65bc34-2bc2-4f52-a9b3-1cb08324eb79	2024-07-19	Warnings	Exact identifier ndc (package): 62217-200-20 ndc (product): 62217-200 ndc11 (package): 62217020020 spl id: 1d9eb3d8-4244-1150-e063-6294a90a8ae0 spl set id: 1d65bc34-2bc2-4f52-a9b3-1cb08324eb79

Reported adverse events (FAERS/openFDA)#

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