SUNBURN RELIEF GEL- lidocaine hcl gel

Sunburn Relief Gel by

Drug Labeling and Warnings

Sunburn Relief Gel by is a Otc medication manufactured, distributed, or labeled by Amazon.com Services LLC, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine HCl 0.5%

Purpose

External analgesic

Uses

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 clean 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, diazolidinyl urea, menthol, disodium EDTA, blue 1, yellow 5

disclaimer

DISTRIBUTED BY:

Amazon.com Services, Inc.

Seattle, WA 98109 1-877-485-0385

2018 Amazon.com Services, Inc. or its affiliates

All rights reserved. Solimo and all related logos are trademarks of Amazon.com, Inc. or its affiliates

principal display panel

SOLIMO

Sunburn

Relief Fel

PAIN RELIEVING GEL

With aloe vera

With lidocaine HCl

NET WT 8 OZ (226 g)

INGREDIENTS AND APPEARANCE

SUNBURN RELIEF GEL 
lidocaine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72288-005
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 (UNII: 7FLD91C86K)
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: 72288-005-34	226 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/31/2018

Labeler - Amazon (128990418)

Registrant - Vi-Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc		790752542	manufacture(72288-005)