Walgreens
FDA Label NDC 0363-4002

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 0363-4002). 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, otc - purpose, uses, warnings, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Menthol   0.10%

Otc - Purpose

Topical Analgesic

Uses

  • temporary pain relief
  • helps relieve and soothes pain from sunburn, minor burns, cuts, scrapes, skin irritations and insect bites

Warnings

For external use only

When Using This Product

  • avoid contact with eyes.

Stop Use And Ask A Doctor If

  • condition worsens or symptoms persist for more than 7 days.
  • symptoms clear up and occur again within a few days.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed get medical help or contact 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., Propylene Glycol, Glycerin, Polysorbate 20, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Juice, Disodium EDTA, Tocopherol, Diazolidinyl Urea, Blue 1, Yellow 5.

Principal Display Panel

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