FRUIT OF THE EARTH ALOE VERA COOL BLUE- lidocaine hydrochloride 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 Aloe Vera Cool Blue Gel

Active Ingredients

Lidocaine 1.0% (as Lidocaine HCl)

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

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

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

Directions

Other Information: May stain some fabrics.

Inactive Ingredients

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

Fruit of the Earth

Aloe Vera

Cool Blue Gel

567 grams

NDC: 62217-200-20

Label Image

FRUIT OF THE EARTH ALOE VERA COOL BLUE 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ISOCETETH-20 (UNII: O020065R7Z)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
EDETATE SODIUM (UNII: MP1J8420LU)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
SULISOBENZONE (UNII: 1W6L629B4K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-200-20567 g in 1 BOTTLE; Type 0: Not a Combination Product09/10/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/10/2014
Labeler - Fruit of the Earth, Inc. (079559467)
Establishment
NameAddressID/FEIBusiness Operations
Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(62217-200)

Revised: 12/2017
Document Id: 60a601b3-8ab7-7a45-e053-2a91aa0a2e0b
Set id: 1d65bc34-2bc2-4f52-a9b3-1cb08324eb79
Version: 3
Effective Time: 20171218
 
Fruit of the Earth, Inc.