Sunburnt Plus Gel
FDA Label NDC 68229-600

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Quest Products, Llc. for the product Sunburnt Plus (NDC 68229-600). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

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

Otc - Keep Out Of Reach Of Children

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, ethyl alcohol, echnicacea 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?

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Principal Display Panel - 142 G Tube Carton

NEW!

SUN
BURNT®
PLUS

PAIN RELIEF GEL
with LIDOCAINE HCL 4%

FAST RELIEF FOR
PAIN & ITCH

ULTRA
HYDRATING
+
NOURISHING
BOTANICALS

NON-STICKY
FORMULA

Net Wt 4 oz (142 g)

* Please review the disclaimer below.