Aruba Aloe Alcoholada Cream
FDA Label NDC 53675-212

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aruba Aloe Balm Nv for the product Aruba Aloe Alcoholada (NDC 53675-212). 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 drug facts, active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Lidocaine Hydrochloride 0.5%

Purpose

Pain Relieving Gel

Uses

For the temporary relief of pain and itching associated with minor burns, sunburn, insect bites, or 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 the eyes.

Stop Use And Ask A Doctor If

conditions worsens, or if symptoms persist for more than 7 days or clears 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

  • 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: Consult a doctor.

Other Information

  • Store in a cool dry place
  • Protect from heat and light

Inactive Ingredients

Water (Aqua/Eau), Alcohol Denat., Polysorbate 20, Fragrance (Parfum), Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylyl Glycol, Glyceryl Laurate, Glyceryl Undecylenate, 8.5 fl oz (251 mL) Aminomethyl Propanol, FD&C Blue #1 (C.I. 42090).

Package Labeling:

Label0 (Label0)

Label0 (Label0)

* Please review the disclaimer below.