SUNBURN RELIEF- lidocaine hcl 0.5% gel

Sunburn Relief by

Drug Labeling and Warnings

Sunburn Relief by is a Otc medication manufactured, distributed, or labeled by Old East Main CO, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine HCl 0.5%

Purpose

External Analgesic

Use

for the temporary relief of pain and itching associated with

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

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

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

SPL UNCLASSIFIED SECTION

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

Satisfaction

DISTRIBUTED BY DOLGENCORP, LLC

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)

INGREDIENTS AND APPEARANCE

SUNBURN RELIEF 
lidocaine hcl 0.5% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-177
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	5.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-177-34	226 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/30/2019

Labeler - DOLGENCORP, LLC (068331990)

Registrant - Vi-Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc		088520668	manufacture(55910-177)