SUNBURNT PLUS- lidocaine hydrochloride gel 
Quest Products, LLC.

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SUN BURNT ® PLUS

Drug Facts

Active Ingredient

Lidocaine Hydrochloride 4%

Purpose

Topical Pain Relief

Uses

Temporarily relieves pain and itching due to:

Warnings

For external use only

Do not use

  • in large quantities, particularly over raw surfaces or blistered areas
  • if you have an allergy or hypersensitivity to any ingredients

Ask a doctor before use if

  • you have severe sunburn
  • you have a rash or broken or compromised skin

When using this product

  • Avoid contact with eyes

Stop use and ask a doctor

  • condition worsens
  • symptoms last 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

Other Information

Inactive Ingredients

Water, Hydroxyethylcellulose,Glycerin, Phenoxyethanol, Aloe Barbadensis Leaf Juice, D-Panthenol, Calunda Officinalis Extract, Echinacea Purpurea Root Extract, Mannitol, Sodium Hyaluronate, Lactobacillus Ferment, Sodium Hydroxide

PRINCIPAL DISPLAY PANEL - 118mL Tube Carton

PDP

SUNBURNT PLUS 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68229-601
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)  
HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%) (UNII: M825OX60H9)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
PANTHENOL (UNII: WV9CM0O67Z)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
ECHINACEA PURPUREA ROOT (UNII: OS64WTR4KU)  
GLYCERIN (UNII: PDC6A3C0OX)  
MANNITOL (UNII: 3OWL53L36A)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68229-601-021 in 1 CARTON02/23/2024
1NDC:68229-601-01118 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01702/23/2024
Labeler - Quest Products, LLC. (075402441)
Establishment
NameAddressID/FEIBusiness Operations
Fill Tech USA926433855manufacture(68229-601)

Revised: 2/2024
Document Id: 12128c75-015e-8a72-e063-6394a90ae00a
Set id: 12128c75-015d-8a72-e063-6394a90ae00a
Version: 1
Effective Time: 20240223
 
Quest Products, LLC.