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Drug Facts
Sunburnt Plus Gel
FDA Label NDC 68229-601
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 68229-601). 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
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
Pdp (Sunburnt.601.pdp)
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