Amerfresh Medicated Body Powder
FDA Label NDC 87510-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Onest Limited for the product Amerfresh Medicated Body Powder (NDC 87510-001). 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 ingredient                                        purpose, uses, warnings, directions, other information, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient                                        Purpose

Menthol  0.15%                                       Anti - Itch

Zinc Oxide  1.0%                                      Skin Protectant

Uses

Temporarily relieves the pain itch associated with:
• Minor cuts
• Sunburns
• Insect bites
• Scrapes
• Minor burns
• Minor skin irritation

Warnings

For external use only
• Do not use
• Broken skin
• Deep or puncture wounds
• Serious burns

When using this product

  • avoid contact with the eyes
  • Keep away from face and mouth to avoid breathing powder.

    • Stop use and ask a doctor:
    • If the condition worsens
    • Symptoms persist for more than 7 days or clear up and occur again within a few days.
    • Redness, irritation, swelling, or pain persists or increases.

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

Directions

• For adults and children 2 years and older : freely up to 3 or 4 times daily
• For children under 2 years : ask doctor
• For best results dry skin thoroughly before applying.

Other Information

  • This products is sold by weight, not by volumes
  • Settings will occur during handling & shipping

Inactive Ingredients

Acacia Seyal Gum, Eucalyptol, Methyl Salicylate, salicylic Acid, Sodium Bicarbonate, Thymol, Tri-calcium Phosphate, Zea Mays (Corn) starch, Zinc Stearate.

Product Label

Image Description (Label)

Image Description (Label)

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