SUNBURNT PLUS PAIN RELIEF- lidocaine hydrochloride gel

SunBurnt PLUS Pain Relief by

Drug Labeling and Warnings

SunBurnt PLUS Pain Relief by is a Otc medication manufactured, distributed, or labeled by Denison Pharmaceuticals, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Lidocaine hydrochloride 1.0%

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 if

• 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 15-30ºC (59-86ºF)
• do not use if seal under cap is open or missing

Inactive ingredients

water, ethyl alcohol, echinacea angustifolia extract, calendula officinalis extract, cantharis vesicatoria extract, gelidiella acerosa extract, hypnea musciformis extract, cucumis sativus (cucumber) seed extract, aloe barbadensis leaf juice, panthenol, sodium hyaluronate, carbomer, sodium hydroxide, phenoxyethanol, ethylhexylglycerin

Questions or Comments?

1-888-565-2876 Monday through Friday, 9am-5pm EST

SPL UNCLASSIFIED SECTION

Dist. by: Welmedix Consumer Healthcare
Princeton, New Jersey 08540

PRINCIPAL DISPLAY PANEL - 142 g Tube Carton

NEW!

SUN
BURNT®
PLUS
PAIN RELIEF GEL
with LIDOCAINE HCL 1%

FAST RELIEF FOR
PAIN & ITCH

ULTRA
HYDRATING

NOURISHING
BOTANICALS

NON-STICKY
FORMULA

Net Wt 5 oz (142 g)

INGREDIENTS AND APPEARANCE

SUNBURNT PLUS PAIN RELIEF 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-1110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ)
LYTTA VESICATORIA (UNII: 3Q034RO3BT)
GELIDIELLA ACEROSA (UNII: T91K54D6M1)
HYPNEA MUSCIFORMIS (UNII: W6FF9R1FJV)
CUCUMBER SEED (UNII: BT3S9L53JK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Panthenol (UNII: WV9CM0O67Z)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
Sodium hydroxide (UNII: 55X04QC32I)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ethylhexylglycerin (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-1110-21	1 in 1 CARTON	03/15/2018
1		142 g 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 NOT FINAL	part348	03/15/2018

Labeler - Denison Pharmaceuticals, LLC. (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC.		001207208	manufacture(0295-1110)