Medicated Body Powder

Medicated Body Powder
SPL v1
SPL
SPL Set ID e2dd051a-e24a-405b-bc35-382f55be716a
Route
TOPICAL
Published
Effective Date 2015-11-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.15 g) Zinc Oxide (1 g)
Inactive Ingredients
Talc Acacia Eucalyptus Oil Methyl Salicylate Salicylic Acid Thymol Zinc Stearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-11-03

Description

Active Ingredients Menthol        0.15% Zinc Oxide      1.0%


Medication Information

Warnings and Precautions

Warning

For external use only.

Indications and Usage

Uses

For the temporary relief from pain and itching associated with minor cuts and burns, sunburn, scrapes, insect bites, and other minor skin irritation. Also for drying up poison oak, which helps control the growth of fungi associated with athlete's foot and jock itch.

Dosage and Administration

Directions

Use after shower, bath or exercise. Use in footwear and on feet. Dry skin completely before applying. For adults and children over 2 years; apply to affected area not more than 3 or 4 times daily. Children Under 2 Years; Consult a doctor.

Description

Active Ingredients Menthol        0.15% Zinc Oxide      1.0%

Section 50565-1

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Section 50567-7

Avoid contact with eyes.

Section 50569-3

If symptoms persist more than 7 days, worsen with use or return within a few days of cleaning up, discontinue use of this product and consult a doctor.

Section 51727-6

Inactive Ingredients

talc, acacia, eucalyptus oil, methyl salicylate, salicylic acid, thymol, zinc stearate.

Section 51945-4

PRINCIPAL DISPLAY PANEL

MEDICATED BODY POWDER

NET WT. 10 OZ. (283g)

Section 55105-1

Purpose

Anti-itch

Section 55106-9

Active Ingredients

Menthol        0.15%

Zinc Oxide      1.0%


Structured Label Content

Indications and Usage (34067-9)

Uses

For the temporary relief from pain and itching associated with minor cuts and burns, sunburn, scrapes, insect bites, and other minor skin irritation. Also for drying up poison oak, which helps control the growth of fungi associated with athlete's foot and jock itch.

Dosage and Administration (34068-7)

Directions

Use after shower, bath or exercise. Use in footwear and on feet. Dry skin completely before applying. For adults and children over 2 years; apply to affected area not more than 3 or 4 times daily. Children Under 2 Years; Consult a doctor.

Warnings and Precautions (34071-1)

Warning

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Section 50567-7 (50567-7)

Avoid contact with eyes.

Section 50569-3 (50569-3)

If symptoms persist more than 7 days, worsen with use or return within a few days of cleaning up, discontinue use of this product and consult a doctor.

Section 51727-6 (51727-6)

Inactive Ingredients

talc, acacia, eucalyptus oil, methyl salicylate, salicylic acid, thymol, zinc stearate.

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL

MEDICATED BODY POWDER

NET WT. 10 OZ. (283g)

Section 55105-1 (55105-1)

Purpose

Anti-itch

Section 55106-9 (55106-9)

Active Ingredients

Menthol        0.15%

Zinc Oxide      1.0%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)