Active Ingredients
Lidocaine 0.8% (as Lidocaine HCl)
Fruit Of The Earth Sun Town City Aloe Vera After Sun With Lidocaine Hcl Gel
FDA Label NDC 62217-070
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fruit Of The Earth, Inc. for the product Fruit Of The Earth Sun Town City Aloe Vera After Sun With Lidocaine Hcl (NDC 62217-070). 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 active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External Analgesic
Uses
For the temporary relief of pain and itching associated with sunburn, minor burns, minor cuts, scrapes, insect bites, and minor skin irritations.
Warnings
For External Use Only
Do Not Use
in large quantities, particularly over raw surfaces or blistered areas
When Using This Product
avoid contact with eyes. If contact occurs, rinse with water to remove.
Stop Use And Ask A Doctor If
• condition worsens • symptoms persist for more than 7 days • symptoms clear up and occur again within a few days
Keep Out Of Reach Of Children.
If swallowed, seek medical help or contact a Poison Control Center immediately.
Directions
- Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
- Children under 2 years of age: Ask a doctor.
Other Information:
May stain some fabrics.
Inactive Ingredients:
water, aloe barbadensis leaf juice, alcohol denat., propylene glycol, laureth-23, glycerin, polysorbate 20, allantoin, carbomer, triethanolamine, menthyl lactate, disodium EDTA, menthol, aleurites moluccarnus seed extract, carica papaya (papaya) fruit extract, colocasia antiquorum root extract, mangifera indica (mango) fruit extract, passiflora incarnata flower extract, plumeria acutifolia flower extract, psidium guajava fruit extract, tocopheryl acetate, tocopherol, phenoxyethanol, benzyl alcohol, fragrance, Blue 1, Yellow 5.
Package Label.Principal Display Panel
83645ef1 (83645ef1)
83648ef1 (83648ef1)
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