FDA Label for Medicated Body

View Indications, Usage & Precautions

Medicated Body Product Label

The following document was submitted to the FDA by the labeler of this product Universal Distribution Center Llc. 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

Anti-itch


Indications & 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.


Warnings



Warning

For external use only.


Otc - When Using



Avoid contact with eyes.


Otc - Ask Doctor



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.


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

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.


Inactive Ingredient



Inactive Ingredients

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


Package Label.Principal Display Panel



PRINCIPAL DISPLAY PANEL

MEDICATED BODY POWDER

NET WT. 10 OZ. (283g)


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