LUCKY SUPERSOFT SUNBURN RELIEF- lidocaine hydrochloride gel 
Delta Brands 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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LUCKY sunburn relief gel

Drug Facts

Active ingredient

Lidocaine hydrochloride 0.5%

Purpose

External analgesic

Uses

temporarily relieves pain and itching associated with

■ sunburn ■ minor burns ■ minor cuts ■ scrapes ■ minor skin irritations ■ insect bites

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

Stop use and ask a doctor if

condition worsens

or if symptoms persist for more than 7 days

or symptoms clear up and occur again in a few days

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

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

water, glycerin, aloe barbadensis leaf juice, propylene glycol, menthol, disodium EDTA,isopropyl alcohol (0.06% v/v), polysorbate 20, carbomer, sodium hydroxide, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, FD&C yellow no. 5, FD&C blue no. 1

Package Label

Package Label

LUCKY SUPERSOFT  SUNBURN RELIEF
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
MENTHOL (UNII: L7T10EIP3A)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:20276-110-06170 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/02/2019
2NDC:20276-110-08227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/02/2019
Labeler - Delta Brands Inc (102672008)

Revised: 9/2023
 
Delta Brands Inc