Dosing & Uses
Dosage Forms & Strengths
pramoxine/allantoin
topical ointment
- 1%/1.5%
Topical Pain
For temporary relief fof pain associated with dry, chapped lips or cold sores
Apply to affected area q6-8hr PRN
Administration
Apply directly to lips or apply to finger and then cover lips
Topical Pain
For temporary relief of pain associated with dry, chapped lips or cold sores
>2 years: Apply to affected area q6-8hr PRN
<2 years: Safety and efficacy not established
Administration
Apply directly to lips or apply to finger and then cover lips
Adverse Effects
Frequency Not Defined
Irritation
Warnings
Contraindications
Hypersensitivity to any product component
Cautions
For external use only
Do not use in the eyes
If condition worsens, or if symptoms persist for longer than 7 days or clear up and occur again within a few days, discontinue use and consult a physician
Pregnancy & Lactation
Pregnancy Category: Undetermined
Lactation: Unknown if excreted in breast milk
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Pramoxine is a local anesthetic due to inhibition of conduction of nerve impulses from sensory nerves, resulting from an alteration of the cell membrane permeability to ions; allantoin acts as a skin protectant to moisturize and protect lips
