FRUIT OF THE EARTH COOL BLUE ALOE MIST CONTINUOUS- lidocaine hydrochloride spray 
Fruit Of The Earth, Inc.

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Fruit of the Earth Cool Blue Aloe Mist Continuous Spray

Active Ingredients

Lidocaine 1% (as Lidocaine HCl)

Purpose

Topical 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

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.

61332D3

FRUIT OF THE EARTH COOL BLUE ALOE MIST CONTINUOUS 
lidocaine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-095
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS10 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)  
EDETATE SODIUM (UNII: MP1J8420LU)  
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)  
SULISOBENZONE (UNII: 1W6L629B4K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-095-25177 g in 1 CANISTER; Type 0: Not a Combination Product09/12/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01709/12/2014
Labeler - Fruit Of The Earth, Inc. (079559467)

Revised: 10/2024
Document Id: 24c784b5-a8b3-d355-e063-6394a90a337e
Set id: d4caae4c-efba-2453-e053-2995a90a5e5f
Version: 2
Effective Time: 20241018
 
Fruit Of The Earth, Inc.