Health Smart Medicated Body Powder
FDA Label NDC 52862-030

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by International Wholesale Inc Dba Home Smart Products for the product Health Smart Medicated Body (NDC 52862-030). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - ask doctor, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients

Menthol        0.15%

Zinc Oxide      1.0%

Otc - Purpose

Purpose

External Analgesic

Skin Protectant

Indications & Usage

Uses

For the temporary relief of pains and itch associated with:

  • Minor Cuts
  • Scrapes
  • Sunburn
  • Insect Bites
  • Prickly Heat
  • Rashes
  • Minor Burns
  • Minor Skin Irritation
  • Dries the oozing of poison ivy, oak, and sumac.

Warnings

Warnings

For external use only.

Otc - When Using

When using this productavoid contact with eyes.

Otc - Ask Doctor

Consult a doctor and discontinue use if

  • condition worsens
  • symptoms do not get better within 1 week or clear up and occurs again within a few days.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Dosage & Administration

Directions

adults and children 2 years and over

  • apply to the affected area not more than 3 or 4 times daily.
  • children under 2 years of age: consult a physician.
  • for best results, dry skin thoroughly before use.

Other

PRINCIPAL DISPLAY PANEL

HEALTH SMART MEDICATED BODY POWDER

NET WT. 10 OZ. (283g)

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