FDA Label for Cold Sore Fast-acting Pain Relief
View Indications, Usage & Precautions
Cold Sore Fast-acting Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Blistex 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
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| Lidocaine 4.0% (w/w) | External analgesic |
| Glycerin 20% (w/w) | Lip protectant |
Uses
- for the temporary relief of pain and itching associated with fever blisters and cold sores
- relieves dryness and softens cold sores and fever blisters
- softens crusts (scabs) associated with cold sores and fever blisters
- temporarily protects chapped or cracked lips
Warnings
For external use only
Otc - Do Not Use
Do not use in large quantities, particularly over raw surfaces or blistered areas
When Using This Product
- do not get into eyes
Stop Use And Ask A Doctor If
- condition worsens
- symptoms last 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 right away.
Directions
- adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
- children under 2 years of age: do not use, consult a doctor
Other Information
- push and turn cap to open, close tightly after use
- wash hands before and after applying www.blistex.com
Inactive Ingredients
citric acid, disodium EDTA, ethylhexylglycerin, hydroxyethylcellulose, menthol, phenoxyethanol, potassium sorbate, propylene glycol, purified water
Principal Display Panel - 4.25 G Tube Label
NDC 10157-4103-1
Blistex®
DERMATOLOGIST RECOMMENDED
NEW
COLD SORE
FAST-ACTING
PAIN RELIEF
EXTERNAL ANALGESIC / LIP PROTECTANT
IMMEDIATELY
Relieves Pain & Itching
NET WT. 4.25 g (0.15 oz)
* Please review the disclaimer below.
