Medicated
FDA Label NDC 55316-551

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dzb Brands, Llc for the product Medicated (NDC 55316-551). 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, keep out of 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

Active ingredients

Menthol 0.15%

Zinc oxide 1.0%

Purpose

Purpose

External analgesic

Skin protectant

Uses

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

  • minor 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

Warnings

For external use only

When Using This Product

When using this product avoid contact with the eyes

Stop Use

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

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

Disclaimer

This product is not manufractured or distributed by Chattem, Inc., owner of the registered tradmark Gold Bond

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

Advese Reactions

Distributed by: DZA Brands, LLC

2110 Excutive Drive

Salisbury, NC 28147

For Product questions or concerns

contact us at 1-866-322-2439. Please include UPC number and code from package

Principal Display Panel

Healthy

Accents

medicated

body powder

external analgesic

cooling - absorbing- itch relieving

Compare to the active ingredients of Gold Bond Medicated Body Powder

NET WT 10 OZ (283 g)

Image Description (Mm1)

Image Description (Mm1)

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