Health Smart Medicated Body Powder

Health Smart Medicated Body Powder
SPL v4
SPL
SPL Set ID 3bf911c7-02f2-4744-ad87-452b24422ea9
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
Talc Acacia Eucalyptus Oil Methyl Salicylate Salicylic Acid Thymol Zinc Stearate

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

talc, acacia, eucalyptus oil, methyl salicylate, salicylic acid, thymol, 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

talc, acacia, eucalyptus oil, methyl salicylate, salicylic acid, thymol, 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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