SUNBURN RELIEF- lidocaine hcl 0.5% gel 
Old East Main CO

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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Dollar General_005.002-005AC-AD

Active ingredient

Lidocaine HCl 0.5%

Purpose

External Analgesic

Use

for the temporary relief of pain and itching associated with

Warnings

For external use only

When using this product

avoid contact with the eyes

Do not use

in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children

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

Directions

Inactive ingredients

water, propylene glycol, glycerin, Aloe barbadensis leaf juice, triethanolamine, isopropyl alcohol, polysorbate 80, carbomer, phenoxyethanol, benzyl alcohol, menthol, disodium EDTA, blue 1, yellow 5

*This product is not manufactured or distributed by Bayer, distributor of Solaraine Cool Aloe Burn Relief Formula

Distributed By Old East Main Co.

100 MISSION RIDGE, GOODLETTSVILLE, TN 37072

100% Satisfction Guaranteed! (888)309-9030

principal display panel

DS|health

Compare to Solarcaine*

SUNBURN RELIEF

PAIN RELIEVING GEL

with ALOE

Helps relieve the pain, discomfort and itchiness resulting from sunburn

NET WT 8 OZ (226 g)

image description

SUNBURN RELIEF 
lidocaine hcl 0.5% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-177
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5.00 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TROLAMINE (UNII: 9O3K93S3TK)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
MENTHOL (UNII: L7T10EIP3A)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-177-34226 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/30/2019
Labeler - Old East Main CO (068331990)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(55910-177)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(55910-177)

Revised: 1/2023
Document Id: f80bc6ae-a70e-4819-af9b-e02c1c880d83
Set id: 49173ec8-c94a-44c9-8a13-0f4b01b96cd6
Version: 7
Effective Time: 20230116
 
Old East Main CO