FDA.reportPublic FDA data

Fruit of the Earth Cool Blue Aloe Vera Gel with Menthol

Manufacturer
Fruit of the Earth, Inc.
Effective date
2021-08-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:39:09

Label at a glance#

ProductFruit of the Earth Cool Blue Aloe Vera Cooling
Active ingredientMENTHOL, ALLANTOIN
Label structure11 sections

Indications and uses

For the temporary relief of sunburn, minor burns, minor cuts, scrapes, insect bites, minor rashes, minor skin irritations and windburned skin.

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

Menthol 0.5%, Allantoin 0.2%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of sunburn, minor burns, minor cuts, scrapes, insect bites, minor rashes, minor skin irritations and windburned skin.

Warnings

WARNINGS SECTION

  • EXTERNAL USE ONLY

Do not use

OTC - DO NOT USE SECTION

in large quantities, particularly over raw surfaces or blistered areas

When using this product

OTC - WHEN USING SECTION

  • Keep out of eyes and eyelids. If contact with eyes occurs, rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Irritation or rash develops
  • Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • 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.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Vera Gel, Isoceteth-20, Triethanolamine, Carbomer, Benzophenone 4, Tetrasodium EDTA, Propylene Glycol, Methylparaben, Propylparaben, Diazolidinyl Urea, Blue #1.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1310ME1MF11310ME1MF1

13112ME1MF113112ME1MF1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62217-007-332021-07-23C16284748780-1c7ccaba7-1d7c-fd44-e053-dadaa90aa01bFruit of the Earth Cool Blue Aloe Vera Gel with Menthol
62217-007-342021-07-23C16284748780-1c7ccaba7-1d7c-fd44-e053-dadaa90aa01bFruit of the Earth Cool Blue Aloe Vera Gel with Menthol

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62217-00762217-007-33, 62217-007-34

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
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ISOCETETH-20O020065R7ZIACT
TROLAMINE9O3K93S3TKIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
SULISOBENZONE1W6L629B4KIACT
EDETATE SODIUMMP1J8420LUIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
MENTHOLL7T10EIP3AACTIB
ALLANTOIN344S277G0ZACTIB
WATER059QF0KO0RIACT

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
f4da5dfb-0b40-116e-e053-2a95a90ad5024bba3a8d-323b-5f45-e054-00144ff8d46c2023-02-16WarningsExact identifier
spl set id: 4bba3a8d-323b-5f45-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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