Studio 35 External Analgesic Medicated Body Powder
FDA Label NDC 0363-0552

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co for the product Studio 35 External Analgesic Medicated Body (NDC 0363-0552). 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, 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:

  • minor cuts
  • sunburn
  • insect bites
  • 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 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.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RE., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

Questions Or Comments?

Call 1-800-925-4733

Principal Display Panel

Studio 35

EXTERNAL ANALGESIC

MEDICATED BODY POWDER

PAIN RELIEVING POWDER

DOES NOT CONTAIN TALC

COOLING

ITCH RELEIF

ABSORBS MOISTURE

NET WT 10 OZ (283 g)

Label (Studio 35 Powder)

Label (Studio 35 Powder)

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