Healthwise Medicated Extra Body Powder 10 Oz

Healthwise Medicated Extra Body Powder 10 Oz
SPL v1
SPL
SPL Set ID 296c9a9c-e3db-59fe-e063-6294a90a0b62
Route
TOPICAL
Published
Effective Date 2024-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.8 g)
Inactive Ingredients
Zinc Stearate Salicylic Acid Acacia Thymol Sodium Bicarbonate Tricalcium Phosphate Zinc Oxide Eucalyptus Oil Starch, Corn Methyl Salicylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-01

Description

Menthol 0.80%

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Description

Menthol 0.80%

Uses



for the temporary relief of the pain and itch associated with:

■ minor cuts ■ scrapes ■ sunburn ■ insect bites ■ prickly heat ■ rashes ■ minor burns ■ minor skin irritation ■ dries the oozing of poison ivy, oak, and sumac.

Warnings

For external use only

Directions

Directions

■ Adults and children 2 years of age and over: apply freely up to 3 or 4 times daily ■ Children under 2 years: consult a physician ■ For best results, dry skin thoroughly before use.

Active Ingredient

Menthol 0.80%

Inactive Ingredients

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

Questions Or Comments

Call toll-free 1-866-326-1313

When Using This Product

Avoid contact with eyes.

Keep Out of Reach of Children

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Stop Use and Consult A Doctor If

■ Condition worsens ■ Redness, irritation, swelling or pain persists or increases ■ Symptoms do not get better within 7 days or clear up and occur again within a few days.

Healthwise Medicated Extra Body Powder


Structured Label Content

Uses



for the temporary relief of the pain and itch associated with:

■ minor cuts ■ scrapes ■ sunburn ■ insect bites ■ prickly heat ■ rashes ■ minor burns ■ minor skin irritation ■ dries the oozing of poison ivy, oak, and sumac.

Purpose

External analgesic

Warnings

For external use only

Directions

Directions

■ Adults and children 2 years of age and over: apply freely up to 3 or 4 times daily ■ Children under 2 years: consult a physician ■ For best results, dry skin thoroughly before use.

Active Ingredient

Menthol 0.80%

Inactive Ingredients

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

Questions Or Comments (Questions or comments)

Call toll-free 1-866-326-1313

When Using This Product (When using this product)

Avoid contact with eyes.

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Stop Use and Consult A Doctor If (Stop use and consult a doctor if)

■ Condition worsens ■ Redness, irritation, swelling or pain persists or increases ■ Symptoms do not get better within 7 days or clear up and occur again within a few days.

Healthwise Medicated Extra Body Powder (HealthWise Medicated Extra Body Powder)


Advanced Ingredient Data


Raw Label Data

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