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

Fruit of the Earth Cool Blue Aloe Vera Cooling by

Drug Labeling and Warnings

Fruit of the Earth Cool Blue Aloe Vera Cooling by is a Otc medication manufactured, distributed, or labeled by Fruit of the Earth, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Menthol 0.5%

Purpose

External Analgesic

Uses

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

Warnings

For External Use Only

When using this product

avoid contact with eyes. If contact occurs, rinse with water to remove.

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

Keep out of reach of children

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

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 Ingredients:

aloe barbadensis leaf juice, isoceteth-20, triethanolamine, carbomer, allantoin, benzophenone-4, tetrasodium EDTA, propylene glycol, methylparaben, propylparaben, diazolidinyl urea, blue 1, water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FRUIT OF THE EARTH COOL BLUE ALOE VERA COOLING 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62217-080
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

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOCETETH-20 (UNII: O020065R7Z)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
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)
ALLANTOIN (UNII: 344S277G0Z)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62217-080-33	113 g in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2013
2	NDC: 62217-080-34	340 g in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/30/2013

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