FRUIT OF THE EARTH COOL BLUE ALOE VERA COOLING- menthol, allantoin gel

Fruit of the Earth by

Drug Labeling and Warnings

Fruit of the Earth by is a Otc medication manufactured, distributed, or labeled by Fruit of the Earth, Inc., Fruit Of The Earth Research Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Menthol 0.5%, Allantoin 0.2%

Purpose

External Analgesic

Uses

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

Warnings

• EXTERNAL USE ONLY

DO NOT USE

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

When using this product

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

Stop use and ask a doctor if

• 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

• If swallowed, seek medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions

• 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 INGREDIENT

Inactive Ingredients: Aloe Vera Gel, Isoceteth-20, Triethanolamine, Carbomer, Benzophenone 4, Tetrasodium EDTA, Propylene Glycol & Methylparaben & Propylparaben & Diazolidinyl Urea, FD&C Blue #1.

PRINCIPAL DISPLAY PANEL

Fruit of the Earth

COOL BLUE®

ALOE VERA

COOLING GEL

with MENTHOL

For All Minor Cuts, Scrapes, and Burns

4 OZ (113g)

NDC: 62217-007-33

Fruit of the Earth

COOL BLUE®

ALOE VERA

COOLING GEL

with MENTHOL

For All Minor Cuts, Scrapes, and Burns

12 OZ (340g)

NDC: 62217-007-34

INGREDIENTS AND APPEARANCE

FRUIT OF THE EARTH  COOL BLUE ALOE VERA COOLING
menthol, allantoin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62217-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 mg  in 1 g
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	2 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOCETETH-20 (UNII: O020065R7Z)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
SULISOBENZONE (UNII: 1W6L629B4K)
EDETATE SODIUM (UNII: MP1J8420LU)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62217-007-33	113 g in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2017
2	NDC: 62217-007-34	340 g in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/27/2017

Labeler - Fruit of the Earth, Inc. (079559467)

Registrant - Fruit Of The Earth Research Laboratories, Inc. (008193513)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit of the Earth, Inc.		079559467	manufacture(62217-007)