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Fruit of the Earth Aloe Vera Cool Blue

Dosage form: gel
Ingredients: LIDOCAINE 10mg in 1g
Labeler: Fruit of the Earth, Inc.
NDC Code: 62217-200

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.

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
  • For External Use Only

​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

  • 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.

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

FRUIT OF THE EARTH ALOE VERA COOL BLUE 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem 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 
SULISOBENZONE 
Packaging
#Item CodePackage Description
1NDC:62217-200-20567 g in 1 BOTTLE
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/FEIOperations
Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(62217-200)

 
Fruit of the Earth, Inc.

Medically reviewed on Dec 18, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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