FDA Label for Luxury Antiseptic
View Indications, Usage & Precautions
Luxury Antiseptic Product Label
The following document was submitted to the FDA by the labeler of this product Tsm Ithalat Ihracat Sanayi Ve Dis Ticaret Limited Sirketi. 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.
Drug Facts
Active Ingredient
Hydrogen peroxide 3%
Purpose
first aid antiseptic / oral debriding agent
Warnings
For external use only.
Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns.
Stop use and ask a doctor if *swelling, rash, or fever develops. *the condition persists or gets worse. *sore mouth symptoms do not improve in 7 days. *irritation, pain or redness persists or worsens.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact poison control center right away.
Stop Use
Stop use and ask a doctor if *swelling, rash, or fever develops. *the condition persists or gets worse. *sore mouth symptoms do not improve in 7 days. *irritation, pain or redness persists or worsens.
Ask Doctor
Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns.
Do Not Use
Do not use *in the eyes or apply over large areas of the body. *longer than one week.
Dosage & Administration
Directions For use as a first aid antiseptic:
- Clean affected area.
- apply small amount of product on affected area 1-3 times a day.
- may be covered with a sterile bandage.
- For use as an oral debriding agent (oral rinse):
- adults and children 2 years of age and over
- mix with an equal amount of water.
- swish around in the mouth over affected area for at least 1 minute and then spit out. Do not swallow.
- use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor.
- children under 12 years should be supervised in the use of this product.
- children under 2 years of age: consult a dentist or doctor.
Other Information
- Keep tightly closed and in a dark place at room temperature.
- Do not shake bottle. Hold away from face when opening.
Inactive Ingredient
Inactive ingredient purified water
Packaging
* Please review the disclaimer below.