FRUIT OF THE EARTH ALOE VERA COOL BLUE- lidocaine 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%)

Purpose

External Analgesic

Uses

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

Warnings

  • EXTERNAL USE ONLY
  • May stain some fabrics.

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

  • Do not use on puncture wounds

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 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.

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, Tetrasodium EDTA, Blue #1, Methylchloroisothiazolinone, Methylisothiazolinone, Magnesium Sulfate, Magnesium Nitrate, Benzophenone-4.

Principal Display Panel -
Fruit of the Earth
Aloe Vera
Cool Blue Gel
567 grams
NDC: 62217-200-20

CoolBlueGelLabel.jpgLabel1

FRUIT OF THE EARTH ALOE VERA COOL BLUE 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:62217-200
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ISOCETETH-20 
TROLAMINE 
CARBOMER 940 
EDETATE SODIUM 
FD&C BLUE NO. 1 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
MAGNESIUM SULFATE 
MAGNESIUM NITRATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-200-20567 g in 1 BOTTLE; Combination Product Type = C112160
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/10/2014
Labeler - Fruit of the Earth, Inc. (039336490)
Establishment
NameAddressID/FEIBusiness Operations
Fruit of the Earth008193513manufacture(62217-200)

Revised: 9/2014
Document Id: 57fe06d2-add1-4cd6-adf7-b362c3fbbcc5
Set id: 1d65bc34-2bc2-4f52-a9b3-1cb08324eb79
Version: 1
Effective Time: 20140910
 
Fruit of the Earth, Inc.