FDA Label for Antiseptic

View Indications, Usage & Precautions

Antiseptic Product Label

The following document was submitted to the FDA by the labeler of this product Total Resources International. 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.

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Drug Facts


Active Ingredients



Benzalkonium

Chloride 0.13% w/w

Lidocaine

HCI 0.5% w/w


Purpose



First Aid

Antiseptic

Topical

Analgesic


Uses



  • temporary relief of pain associated with minor burns
  • helps protect against harmful bacteria

Warnings



For external use only


Do Not Use



  • in eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, serious burns
  • for more than one week unless directed by a doctor

Otc - Keep Out Of Reach Of Children



Keep out of reach of children If ingested contact a Poison Control Center right away


Directions



  • clean affected area
  • apply small amount not more than 3 times daily
  • children under 2: consult a doctor

Inactive Ingredients



aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax


Principal Display Panel – Pouch Label



BE SMART

GET PREPARED

BURN
CREAM
W/ ALOE VERA • FOR MINOR BURNS

0.03 oz [0.90 g]

SINGLE USE

Made in USA • Mfd. for: TOTAL RESOURCES INTL.
Walnut, California 91789

00-BUR-0009 Rev.01 • NDC #55550-902-21


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