- Lidocaine - 25mg
Prilocaine - 25mg
Methylparaben - 1.6mg
Propylparaben - 0.4mg
NS Numbing Cream 30 grams (mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use
Dosage and Administration
Adult Patients-Intact Skin. A thicker layer of NS Numbing Cream is applied to intact skin and covered with an occlusive dressing.
Minor Dermal Procedure: For minor procedure such as intravenous cannulation and venipuncture, apply 2.5 grams of NS Numbing Cream over 20 to 25 cm² of skin surface for at least 1 hour.
Major Dermal Procedure: For more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting, apply 2 grams of NS Numbing Cream per 10 cm² of skin and allow to remain in contact with the skin for at least 2 hours.
Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream. The amount of Lidocaine and Prilocaine absorbed during the period of application.
Adult Female Patients-Genital Mucous Membranes
For minor procedures on the female external genitalia, such as removal of condylomata acuminate, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5 to 10 grams) of NS Numbing Cream for 5 to 10 minutes.
Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the NS Numbing Cream application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of NS Numbing Cream.
Pediatric Patient-Intact Skin
The following are the maximum recommended doses, application areas and application times have not shown cross sensitivity to lidocaine and/or prilocaine, however, NS Numbing Cream based on a child’s age and weight:
Please note: If a patient greater than 3 months old does not meet the minimum weight requirements, the maximum total dose of NS Numbing Cream should be restricted to that which corresponds to the patient’s weight.
Practitioners should carefully instruct caregivers to avoid application of excessive amounts of NS Numbing Cream.
When applying NS Numbing Cream to the skin of young children, care must be taken to maintain careful observation of the child to prevent accidental ingestion of NS Numbing Cream or the occlusive dressing. A secondary protective covering prevent inadvertent disruption of the application site may be useful.
NS Numbing Cream should not be used in neonates with a gestational age less than 37 weeks nor in infants under the age of 12 months who are receiving treatment with methemoglobin-inducing agents.
When NS Numbing Cream (lidocaine 2.5 % and prilocaine 2.5 %) is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.
The amount absorbed in the case of NS Numbing Cream is determined by the area over which it is applied and the duration of application under.
Although the incidence of system adverse reactions with NS Numbing Cream is very low, caution should be exercised, particularly when applying it over large areas and leaving it on for longer than 2 hours. The incidence of systemic adverse reactions can be expected to be directly proportional to the area and time of exposure.
Localized Reactions: During or immediately after treatment with Lidocaine and Prilocaine cream on intact skin, the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation. Rare cases of discrete purpuric or petechial reactions at the application site have been reported. Rare cases of hyperpigmentation following the use of Lidocaine and Prilocaine cream have been reported. The relationship to Lidocaine and Prilocaine cream or the underlying procedure has not been established. In clinical studies on intact skin involving over 1,300 Lidocaine and Prilocaine cream-treated subjects, one or more such local reactions were noted in 56% of patients, and were generally mild and transient, resolving spontaneously within 1 or 2 hours. There were no serious reactions that were ascribed to Lidocaine and Prilocaine.
Two recent reports describe blistering on the foreskin in neonates about to undergo circumcision. Both neonates received 1.0 g of Lidocaine and Prilocaine cream.
In patients treated with Lidocaine and Prilocaine cream on intact skin, local effects observed in the trials included: paleness (pallor or blanching) 37 %, redness (erythema) 30%, alterations in temperature sensations 7%, edema 6%, itching 2% and rash, less than 1%.
In clinical studies on genitak mucous membranes involving 378 Lidocaine and Prilocaine cream-treated patients, one or more application sire reactions, usually mind and transient, were noted in 41% of patients. The most common application site reactions were redness (21%), burning sensation (17%) and edema (10%).
Allergic Reactions: Allergic and anaphylactoid reactions associated with lidocaine and prilocaine can occur. They are characterized by urticarial, angioedema, bronchospasm, and shock. If they occur they should be managed by conventional means. The detection of sensitivity by skin testing is doubtful value.
Precaution for Use
Lidocaine and Prilocaine cream (lidocaine 2.5% and prilocaine 2.5%) is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.
2. Special precaution for use
Labor and Delivery: Neither lidocaine nor prilocaine are contraindicated in labor and delivery. Should Lidocaine and Prilocaine cream be used concomitantly with other products containing lidocaine and/or prilocaine, cumulative doses from all formulations must be considered.
Nursing Mothers: Lidocaine, and probably prilocaine, are excreted in human milk. Therefore, caution should be exercised when Lidocaine and Prilocaine cream is administered to a nursing mother since the milk:plasma ratio of lidocaine is 0.4 and is not determined for prilocaine.
Pediatric Use: Controlled studies of Lidocaine and Prilocaine cream in children under the age of seven years have shown less overall benefit than in older children or adults. These results illustrate the importance of emotional and psychological support of younger children undergoing medical or surgical procedures.
Lidocaine and Prilocaine cream should be used with care in patients with conditions or therapy associated with methemoglobinemia.
3. General precautions
Repeated dose of Lidocaine and Prilocaine cream may increase blood levels of Lidocaine and Prilocaine. Lidocaine and Prilocaine cream should be used with caution in patients who may be more sensitive to the systemic effects of Lidocaine and Prilocaine including acutely ill, debilitated, or elderly patients.
Lidocaine and Prilocaine cream should not be applied to open wounds.
Care should be taken not to allow Lidocaine and Prilocaine cream to come in contact with the aye because animal studies have demonstrated severe eye irritation. Also the loss of protective reflexes can permit corneal irritation and potential abrasion. Absorption of Lidocaine and Prilocaine cream in conjunctival tissues has not been determined. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns.
Patients allergic to paraminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine and/or prilocaine, however, Lidocaine and Prilocaine cream should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain.
Lidocaine and Priloocaine have been shown to inhibit viral bacterial growth. The effect of Lidocaine and Prilocaine cream on intradermal injections of live vaccines has not been determined.
4. Caution in storage / handling
- Do not apply near eyes or open wounds.
- Keep out of the reach of children.
- If your child becomes dizzy, excessively sleepy, or develops duskiness of the face or lips after applying Lidocaine and Prilocaine cream, remove the cream and contact the child’s physician at once.
Storage and Expiry Date
- Store at room temperature (1~30 C֯)
- Expiry date: 36months from manufacturing date.
30g AL tube