pramoxine/calamine topical (OTC)

Frequency Not Defined

Irritation

Pruritus

Contraindications

Hypersensitivity to any product component

Cautions

For external use only

Do not use in the eyes

Do not use on blistered or broken skin

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 reassess therapy

Do not apply to wounds or damaged skin.

Do not bandage tightly

Keep out of reach of children; if swallowed, get medical help or contact a Poison Control Center immediately

Pregnancy Category: Undetermined, caution advised

Lactation: Unknown if excreted in breast milk; exercise caution

Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs

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.

Mechanism of Action

Pramoxine: Local anesthetic due to inhibition of conduction of nerve impulses from sensory nerves, resulting from an alteration of the cell membrane permeability to ions

Calamine: Protectant and astringent properties

Absorption

Onset: 3-5 min