FRUIT OF THE EARTH COOL BLUE ALOE VERA COOLING- menthol gel 
Fruit of the Earth, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Fruit of the Earth Cool Blue Aloe Vera Gel with Menthol

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

Keep out of reach of children

Directions

Inactive Ingredients:

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

13104ME2F2

13112ME2F2

FRUIT OF THE EARTH COOL BLUE ALOE VERA COOLING 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-080-33113 g in 1 BOTTLE; Type 0: Not a Combination Product09/30/2013
2NDC:62217-080-34340 g in 1 BOTTLE; Type 0: Not a Combination Product09/30/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/30/2013
Labeler - Fruit of the Earth, Inc. (079559467)

Revised: 7/2021
Document Id: c85ef709-c883-8d32-e053-2995a90a79a7
Set id: c85f0438-d084-c80d-e053-2995a90a63b6
Version: 1
Effective Time: 20210730
 
Fruit of the Earth, Inc.