Topcare Everyday After Sun Cooling Gel
FDA Label NDC 36800-953

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Everyday After Sun Cooling (NDC 36800-953). 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 ingredient, 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

Active Ingredient

Lidocaine hydrochloride 0.5%

Purpose

External Analgesic

Uses

temporarily relieves pain and itching due to:

  • minor skin irritations
  • sunburn
  • minor burns
  • scrapes
  • minor cuts
  • insect bites

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 gets worse
  • symptoms last more than 7 days
  • symptoms clear up and occur again in a few days

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

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

Inactive Ingredients

aloe barbadensis leaf juice, water, isopropyl alcohol, propylene glycol, glycerin, triethanolamine, carbomer, polysorbate 80, diazolidinyl urea, menthol, disodium EDTA, yellow 5, blue 1

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