SUNBURNT PLUS PAIN RELIEF- lidocaine hydrochloride gel 
Welmedix LLC dba Welmedix Consumer Healthcare

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SunBurnt® PLUS Pain Relief Gel

Drug Facts

Active ingredient

Lidocaine hydrochloride 1.0%

Purpose

External analgesic

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 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

Other information

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

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)

PRINCIPAL DISPLAY PANEL - 142 g Tube Carton
SUNBURNT PLUS PAIN RELIEF 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24330-240
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24330-240-011 in 1 CARTON03/15/2018
1142 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34803/15/2018
Labeler - Welmedix LLC dba Welmedix Consumer Healthcare (830387812)

Revised: 3/2018
Document Id: cd41cc55-ae90-4c02-a405-cc81cd06ce2e
Set id: 6363c695-f801-407d-a4e1-b0d9cfa0a273
Version: 1
Effective Time: 20180313
 
Welmedix LLC dba Welmedix Consumer Healthcare