SPL v1
SPL
SPL Set ID 2dd63063-45c1-4029-99ac-0962a27a5ddc
Route
TOPICAL
Published
Effective Date 2017-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1.5 mg) Zinc Cation (10 mg)
Inactive Ingredients
Starch, Corn Sodium Bicarbonate Tricalcium Phosphate Gum Talha Eucalyptol Methyl Salicylate Salicylic Acid Thymol Zinc Stearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-02-07
Description

Menthol         0.15% Zinc Oxide     1.0%

Purpose

External analgesic Skin protectant

Medication Information

Purpose

External analgesic

Skin protectant

Description

Menthol         0.15% Zinc Oxide     1.0%

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
Section 42229-5

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

Warnings

For external use only.

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
Active Ingredients

Menthol         0.15%

Zinc Oxide     1.0%

Inactive Ingredients

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

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)

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.

Structured Label Content

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
Section 42229-5 (42229-5)

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

Purpose

External analgesic

Skin protectant

Warnings

For external use only.

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
Active Ingredients

Menthol         0.15%

Zinc Oxide     1.0%

Inactive Ingredients

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

Questions Or Comments? (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)

When Using This Product (When using this product)

avoid contact with the eyes.

Stop Use and Ask A Doctor (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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:16.000088 · Updated: 2026-03-14T22:54:36.982637