FDA Label for Health Smart Medicated Body

View Indications, Usage & Precautions

Health Smart Medicated Body Product Label

The following document was submitted to the FDA by the labeler of this product International Wholesale Inc Dba Home Smart Products. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredients

Menthol        0.15%

Zinc Oxide      1.0%


Otc - Purpose



Purpose

External Analgesic

Skin Protectant


Indications & 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.

Warnings



Warnings

For external use only.


Otc - When Using



When using this product avoid contact with eyes.


Otc - Ask Doctor



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.

Otc - Keep Out Of Reach Of Children



Keep out of reach of children

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


Dosage & 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.

Inactive Ingredient



Inactive Ingredients

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


Other



PRINCIPAL DISPLAY PANEL

HEALTH SMART MEDICATED BODY POWDER

NET WT. 10 OZ. (283g)


Package Label.Principal Display Panel




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