FRUIT OF THE EARTH SUN TOWN CITY ALOE VERA AFTER SUN WITH LIDOCAINE HCL- 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 Sun Town City Aloe Vera After Sun Gel with Lidocaine HCL

Active Ingredients

Lidocaine 0.8% (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

Other information:

May stain some fabrics.

Inactive ingredients:

water, aloe barbadensis leaf juice, alcohol denat., propylene glycol, laureth-23, glycerin, polysorbate 20, allantoin, carbomer, triethanolamine, menthyl lactate, disodium EDTA, menthol, aleurites moluccarnus seed extract, carica papaya (papaya) fruit extract, colocasia antiquorum root extract, mangifera indica (mango) fruit extract, passiflora incarnata flower extract, plumeria acutifolia flower extract, psidium guajava fruit extract, tocopheryl acetate, tocopherol, phenoxyethanol, benzyl alcohol, fragrance, Blue 1, Yellow 5.

83645EF1

83648EF1

FRUIT OF THE EARTH SUN TOWN CITY ALOE VERA AFTER SUN WITH LIDOCAINE HCL 
lidocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-070
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE8 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
LAURETH-23 (UNII: N72LMW566G)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALLANTOIN (UNII: 344S277G0Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
TROLAMINE (UNII: 9O3K93S3TK)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
MENTHOL (UNII: L7T10EIP3A)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)  
MANGO (UNII: I629I3NR86)  
GUAVA (UNII: 74O70D6VG0)  
PAPAYA (UNII: KU94FIY6JB)  
PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z)  
COLOCASIA ESCULENTA ROOT (UNII: H7B71Q0G0D)  
ALEURITES MOLUCCANA SEED (UNII: J87WJ3E7VW)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-070-80227 g in 1 BOTTLE; Type 0: Not a Combination Product12/09/2019
2NDC:62217-070-68453 g in 1 BOTTLE; Type 0: Not a Combination Product12/09/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/09/2019
Labeler - Fruit of the Earth, Inc. (079559467)

Revised: 7/2021
Document Id: c7a833b9-5238-1b63-e053-2a95a90acdcd
Set id: c7a833bd-7457-73a3-e053-2a95a90ac53f
Version: 1
Effective Time: 20210721
 
Fruit of the Earth, Inc.