SUNBURNT PLUS- lidocaine hydrochloride gel

SunBurnt PLUS by

Drug Labeling and Warnings

SunBurnt PLUS by is a Otc medication manufactured, distributed, or labeled by Quest Products, LLC., Fill Tech USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Lidocaine Hydrochloride 4%

Purpose

Topical Pain Relief

Uses

Temporarily relieves pain and itching due to:

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

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

• clean skin and apply to affected area
• adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily
• children under 2 years of age: ask a doctor

Other Information

• store at 15-30°C (59-86°F)
• do not use if seal under cap is open or missing

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

INGREDIENTS AND APPEARANCE

SUNBURNT PLUS 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68229-601
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68229-601-02	1 in 1 CARTON	02/23/2024
1	NDC: 68229-601-01	118 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/23/2024

Labeler - Quest Products, LLC. (075402441)

Establishment
Name	Address	ID/FEI	Business Operations
Fill Tech USA		926433855	manufacture(68229-601)