FDA Label for Zilactin Early Relief Cold Sore
View Indications, Usage & Precautions
Zilactin Early Relief Cold Sore Product Label
The following document was submitted to the FDA by the labeler of this product Applied Laboratories, Inc.. 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.
Other
Drug Facts
Active Ingredient
Benzyl alcohol 10%
Purpose
Cold sore/fever blister treatment, Oral pain reliever
Use
temporarily relieves pain caused by:
- cold sores/fever blisters
- canker sores, mouth sores
- gum irritations
Flammable:
- keep away from fire or flame
Stop Use And Ask A Physician If
- sore mouth symptoms do not improve in 7 days
- condition worsens or symptoms clear up and occur again within a few days
- swelling, rash or fever develops
- irritation, pain or redness persists or worsens
- apply only to affected area
- do not exceed recommended dosage
- avoid contact with the eyes
- do not use for more than 7 days unless directed by a physician or dentist
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.
Directions
| adults and children 2 years and older | dry affected area. Apply with cotton swab or clean finger up to 4 times daily. Allow to dry 30-60 seconds. |
| children under 12 years | adult supervision should be given in the use of this product |
| children under 2 years | do not use, consult a physician or dentist |
Other Information
- do not peel off protective film. Attempting to peel off film may result in skin irritation or tenderness. To remove film, first apply another coat of Zilactin to film, and immediately wipe the area with a moist gauze pad or tissue.
- contains alcohol 68% by volume
- store at 15-30°C (59-86°F)
Inactive Ingredients
boric acid, hydroxypropylcellulose, propylene glycol, purified water, salicylic acid, SD alcohol 37, tannic acid
Manufactured for: Blairex Laboratories, Inc. P.O. Box 2127 Columbus, IN 47202 USA
Otc - Questions
Questions or Comments?
Call TOLL FREE 1-800-252-4739
www.zilactin.com
Package Label.Principal Display Panel
PROMOTES HEALING
Cold Sore/Fever Blister/Oral Pain Treatment
Zilactin® Early Relief Cold Sore Gel
- Bioadhesive Promotes Healing
- Relieves Pain for up to 6 Hours
Net wt. 0.25 oz (7.1g)
* Please review the disclaimer below.