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 4.0%

Purpose

External analgesic

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, Propanediol,Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Calunda Officinalis Extract, Cucumis Sativus (Cucumber) Seed Extract, Panthenol, Dimethyl Isosorbide, Caprylyl Glycol, Chlorophenesin, Phenoxyethanol, Sodium Hyaluronate, Tocopheryl Acetate

Questions or Comments?

Sunburnt.com

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: 68229-600
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
PROPANEDIOL (UNII: 5965N8W85T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%) (UNII: M825OX60H9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
PANTHENOL (UNII: WV9CM0O67Z)
CUCUMBER SEED (UNII: BT3S9L53JK)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68229-600-01	1 in 1 CARTON	07/01/2020
1	NDC: 68229-600-02	118.294 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	07/01/2020

Labeler - Quest Products, LLC. (075402441)

Establishment
Name	Address	ID/FEI	Business Operations
Fill Tech USA		926433855	manufacture(68229-600)