Medicated Body Powder
FDA Label NDC 52000-038

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Universal Distribution Center Llc for the product Medicated Body (NDC 52000-038). 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, otc - when using, otc - stop use, otc - 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

Menthol         0.15%

Zinc Oxide     1.0%

Purpose

External analgesic

Skin protectant

Uses

for the temporary relief of pain and itching associated with:

  • Backache
  • Minor Burns
  • Minor Skin Irritations
  • Minor Cuts
  • Sunburn
  • Insect Bites
  • Ooozing and weeping of poison ivy, poison oak and poison sumac can be dried using Universal Medicated Powder

Warnings

For external use only.

Otc - When Using

When using this product avoid contact with the eyes.

Otc - 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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center  (1-800-222-1222) immediately.

Directions

  • Adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily
  • Children under 2 years of age: consult a doctor
  • For best results, dry area thoroughly before applying

Inactive Ingredients

Zea mays (corn) starch, sodium bicarbonate,  tricalcium phosphate, acacia seyal gum, eucalyptol, methyl salicylate, salicylic acid, thymol, zinc stearate

Other

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

Package Label.Principal Display Panel

Principal Display Panel

Medicated Body Powder

NET WT. 10 oz (283 g)

Label (Body Powder)

Label (Body Powder)

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