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.

Active Ingredients



Menthol         0.15%

Zinc Oxide     1.0%


Purpose



External analgesic

Skin protectant


Uses



for the temporary relief of pain and itching associated with:

  • Backache
  • Minor Burns
  • Minor Skin Irritations
  • Minor Cuts
  • Sunburn
  • Insect Bites
  • Ooozing and weeping of poison ivy, poison oak and poison sumac can be dried using Universal Medicated Powder

Warnings



For external use only.


Otc - When Using



When using this product avoid contact with the eyes.


Otc - Stop Use



Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center  (1-800-222-1222) immediately.


Directions



  • Adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily
  • Children under 2 years of age: consult a doctor
  • For best results, dry area thoroughly before applying

Inactive Ingredients



Zea mays (corn) starch, sodium bicarbonate,  tricalcium phosphate, acacia seyal gum, eucalyptol, methyl salicylate, salicylic acid, thymol, zinc stearate


Other



This product is sold by weight, not by volume. Some settling may occur during handling and shipping.


Package Label.Principal Display Panel



Principal Display Panel

Medicated Body Powder

NET WT. 10 oz (283 g)


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