Walgreens
FDA Label NDC 0363-4012

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co. for the product Walgreens (NDC 0363-4012). 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, when using this product, stop use and ask a doctor if, keep out of the reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Lidocaine 0.7%

Menthol  0.2%


Purpose

External Analgesic

External Analgesic

Uses

  • temporary relief of pain and itching
  • helps relieve and soothes pain from sunburn, minor burns, cuts, scrapes, skin irritations and 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.

Stop Use And Ask A Doctor If

  • conditions worsens or if symptoms persists for more than 7 days.
  • symptoms clear up and occur again within a few days.

Keep Out Of The 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: do not use, ask a doctor.

Inactive Ingredients

Water, Alcohol Denat., Glycerin, Polysorbate 20, Carbomer, Aloe Barbadensis Leaf Juice, Benzophenone-4, Tocopherol, Imidazolidinyl Urea, Blue 1.


Principal Display Panel

Well at

Walgreens

WALGREENS PHARMACIST RECOMMENDED

PAIN RELIEVING

Aloe

Vera

Gel

With Lidocaine

and Menthol

Cools, soothes

and moisturizes

NET WT 16 OZ (453 g)

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Zwa004c0.jpg (Zwa004c0)





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