Medicated Body Powder

Medicated Body Powder
SPL v4
SPL
SPL Set ID 2a59a847-cc7a-42cf-b49a-92e7254c1629
Route
TOPICAL
Published
Effective Date 2024-06-24
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 DRUG Active Since 2017-12-04

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

• Backache • Minor Burn • Minor Skin Irritations

• Minor Cut • Sunburn • Insect Bites

• Ooozing and weeping of poison ivy, poison oak and poison sumac can be dried using Universal Medicated Powder

Section 42229-5

WITH ESSENTIAL OILS

Daily Use Leaves Skin Feeling Fresh & Healthy

PURE CORNSTARCH

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

Distributed By:

Universal Distribution Center

Edison, NJ 08817

www.universaldc.com

Made in India

Section 50565-1

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

Warning

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.

Packaging

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
Drug Facts

Active Ingredient

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


Structured Label Content

Uses

for the temporary relief of pain and itching associated with

• Backache • Minor Burn • Minor Skin Irritations

• Minor Cut • Sunburn • Insect Bites

• Ooozing and weeping of poison ivy, poison oak and poison sumac can be dried using Universal Medicated Powder

Section 42229-5 (42229-5)

WITH ESSENTIAL OILS

Daily Use Leaves Skin Feeling Fresh & Healthy

PURE CORNSTARCH

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

Distributed By:

Universal Distribution Center

Edison, NJ 08817

www.universaldc.com

Made in India

Section 50565-1 (50565-1)

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

Purpose

External analgesic

Skin Protectant

Warning (WARNING)

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.

Packaging

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
Drug Facts

Active Ingredient

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


Advanced Ingredient Data


Raw Label Data

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