Health Smart Medicated Body Powder (talc Free)

Health Smart Medicated Body Powder (talc Free)
SPL v6
SPL
SPL Set ID 044870e2-ebac-a095-e063-6294a90a2751
Route
TOPICAL
Published
Effective Date 2014-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.15 g) Zinc Oxide (1 g)
Inactive Ingredients
Tricalcium Phosphate Sodium Bicarbonate Salicylic Acid Acacia Eucalyptus Oil Methyl Salicylate Thymol Zinc Stearate Zea Mays Subsp. Mays Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-02-27

Description

Active Ingredients Menthol        0.15% Zinc Oxide      1.0%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Uses

For the temporary relief of pains 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.

Dosage and Administration

Directions

adults and children 2 years and over

  • apply to the affected area not more than 3 or 4 times daily.
  • children under 2 years of age: consult a physician.
  • for best results, dry skin thoroughly before use.
Description

Active Ingredients Menthol        0.15% Zinc Oxide      1.0%

Section 42229-5

PRINCIPAL DISPLAY PANEL

HEALTH SMART MEDICATED BODY POWDER

NET WT. 10 OZ. (283g)

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

When using this productavoid contact with eyes.

Section 50569-3

Consult a doctor and discontinue use if

  • condition worsens
  • symptoms do not get better within 1 week or clear up and occurs again within a few days.
Section 51727-6

Inactive Ingredients

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

Section 51945-4

Section 55105-1

Purpose

External Analgesic

Skin Protectant

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 of pains 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.

Dosage and Administration (34068-7)

Directions

adults and children 2 years and over

  • apply to the affected area not more than 3 or 4 times daily.
  • children under 2 years of age: consult a physician.
  • for best results, dry skin thoroughly before use.
Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 42229-5 (42229-5)

PRINCIPAL DISPLAY PANEL

HEALTH SMART MEDICATED BODY POWDER

NET WT. 10 OZ. (283g)

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)

When using this productavoid contact with eyes.

Section 50569-3 (50569-3)

Consult a doctor and discontinue use if

  • condition worsens
  • symptoms do not get better within 1 week or clear up and occurs again within a few days.
Section 51727-6 (51727-6)

Inactive Ingredients

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

External Analgesic

Skin Protectant

Section 55106-9 (55106-9)

Active Ingredients

Menthol        0.15%

Zinc Oxide      1.0%


Advanced Ingredient Data


Raw Label Data

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