Medicated
FDA Label NDC 0869-0551

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Vi-jon for the product Medicated (NDC 0869-0551). 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 reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Menthol 0.15%

Zinc oxide 1.0%

Purpose

External analgesic

Skin protectant

Uses

Uses for the temporary relief of paina and itching due to:

  • monor cuts
  • sunburn
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac
  • scrapes
  • minor burns
  • minor skin irritations
  • dries the oozing and weeping of:

    • poison ivy
    • poison oak
    • poison sumac

Warnings

For external use only

When Using This Product

avoid contact with the eyes

Stop Use And Ask A Doctor If

condition worsens, or if symptoms persist for more than 7 days or clear 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 - do not use, consult a doctor

  • for best results dry skin thoroughly before applying

Inactive Ingredients

 talc, acacia, eucalyptol, methyl salicylate, salicylic acid, thymol, zinc stearate

Disclaimer

This product is sold by weight, not by volume. Some settling may occur during handling and shipping

Made in the USA with US and foreign components

Adverse Reactions

Vi-Jon

One Swan Drive

Smyrna, TN 37167

Principal Display Panel

NDC 0869-0551-38

SWAN

medicated

Body Powder

skin protectant/topical analgesic

triple action

  • Cooling
  • Absorbing
  • Itch Relieving
  • Compare to Active Ingredients of Gold Bond Medicated Body Powder

    NET WT 10 OZ (283 G)

    Image Description (Mm1)

    Image Description (Mm1)

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