Frequently Asked Questions
Temporary Stinging on Application: The usual sensation when Calmoseptine® Ointment is applied is a gentle cooling. However, when nerve endings are exposed due to denuded skin, the stinging on application may occur. This does not indicate a danger to the patient, and it will usually subside within 30 seconds. After one or two application, the skin is usually healed enough so that the stinging no longer occurs.
Note: If the patient cannot tolerate the sensation, remove the ointment by one of the methods described below.
Calmoseptine® Ointment acts as a barrier to proects skin from moisture and irritating substances. This barrier function also helps protect the skin from drying out. In addition it has ingredients that help to draw moisture away from too moist or inflamed areas. Thus, it helps to maintain a healthy moisture balance for your skin.
Calmoseptine® Ointment was originally developed for use on infants. We do not recommend that it be used on premature newborns.
In adults and children Calmoseptine® Ointment can be used as often as needed to provide protection and relief. On newborn infants under a month (neonates), we recommend using it only 4 times a day and not to cover more than 1/8th of the body.
It only takes a thin layer for Calmoseptine® Ointment to be effective. In most cases, using too much will not cause any problems but it can be messy. Under ostomy appliances only a very small amount should be used and it must be rubbed in well. Add a small amount of stoma powder to make wafer adhere better.
We have had very few reports of allergic reactions to Calmoseptine® Ointment. Calmoseptine® Ointment does not contain Latex or any "food products" such as nut, nut oils, wheat, gluten, fish oils or dairy derivatives. People with allergies to Lanolin or Menthol may react to Calmoseptine® Ointment.
Calmoseptine® Ointment was formulated for use on intact or mildly damaged skin. We do not recommend using it in deep wounds nor on mucous membranes. However, many people have used it without problems on skin transitional areas, close to mucous membranes. These include on the lips, around the anus and around the vaginal opening in women. Calmoseptine® Ointment should not be used in or around the eyes.
Country to country, expiration date laws vary. Some countries require and expiration date; however, in no event shall the expiration date of Calmoseptine® Ointment be less than 3 years.
For inquiries within the United Staes, please refer to the Electronic Code of Federal Regulations (e-CFR) Title 21 Section 211.137 subsection (h):
Pending consideration of a proposed exemption, published in the Federal Register of September 29, 1978, the requirements in this section shall not be enforced for human OTC drug products if their labeling does not bear dosage limitations and they are stable for at least 3 years as supported by appropriate stability data.
[43 FR 45077, Sept. 29, 1978, as amended at 46 FR 56412, Nov. 17, 1981; 60 FR 4091, Jan. 20, 1995]
How to Apply Calmoseptine® Ointment
Cleanse the injured skin or area to be protected prior to application using a mild skin cleanser, normal saline or water.
Pat dry, or allow to air dry.
Apply a thin layer, 2-4 times daily, to affected area, or as often as necessary to promote comfort and protection. A thick layer will not harm the patient, but it is not necessary and often is messy.
When using Calmoseptine® Ointment as a moisture barrier, it is not necessary to thoroughly remove the ointment from the skin with each diaper or dressing change. It is sufficient to cleanse and remove waste material, leaving a base layer of the ointment. Reapply only where necessary.
Gently clean the skin with a mild cleanser and/or water
Rinse with clean water.
Pat the area dry with a clean towel or gauze.
Apply a small amount of Calmoseptine® Ointment to cover the area completely.
Repeat after each bowel movement or when skin becomes wet with urine or drainage. It is not necessary to remove all of the Calmoseptine® Ointment when soiling occurs. Simply cleanse soiled area and reapply the Calmoseptine® Ointment where needed to provide complete protection.
Gently cleanse area with normal saline, mild skin cleanser or soap and water.
Apply a thin layer of Calmoseptine® Ointment to the skin around the tube.
If necessary to control drainage and protect clothing, cover the ointment with a drain sponge or other dressing.
Twice a day application is usually sufficient. If the dressing becomes saturated, it should be replaced more frequently, not reinforced. A thick dressing holds the drainage against the skin and can make the problem worse.
It is not necessary to remove all of the Calmoseptine® Ointment with each dressing change. Simply wipe drainage away and reapply Calmoseptine® Ointment and dressing.
Cleanse area gently and pat or air dry. It is very important that the area is thoroughly dry.
Apply a small amount of Calmoseptine® Ointment.
Spread thinly and rub in well.
Reapply once or twice daily.
- Remove dressing and cleanse the wound as ordered. Use wound care solution to also cleanse drainage from the surrounding skin. Dry the skin. Avoid scrubbing or drying wound edges.
- Apply a thin layer of Calmoseptine® Ointment to skin surrounding the wound.
- Cover the wound and wound edges with an appropriate dressing.
Calmoseptine® Ointment contains zinc oxide so must be entirely removed before each radiation therapy treatment session. For this reason we do not advise using Calmoseptine® Ointment while treatment is in progress, but it is very effective at protecting and soothing the discomfort associated with radiation burns post therapy.
- Gently cleanse the area if there is drainage or soil present.
- Apply a thin layer of Calmoseptine® Ointment. Warming the tube in warm, not hot, water prior to application will soften the ointment and may make application gentler.
- The area may be covered with a soft dressing or left open to air, whichever is more comfortable to the patient.
(Calmoseptine® Ointment does not interfere with normal x-rays)
- Cleanse area and gently dry.
- Apply a thin layer of Calmoseptine® Ointment to rash area, or dab a little on individual insect bites.
- Area may be covered with a dressing or bandage or left open to the air.
Using stoma powder (i.e.: Convatec Stomahesive® Powder, Hollister Premium® Powder) or karaya powder with Calmoseptine® Ointment can help it adhere to weepy and denuded areas. This forms a very protective, somewhat absorbent barrier.
- Cleanse the area using normal saline, water or wound cleanser.
- Very gently pat the area dry with sterile gauze.
- Apply a light dusting of stoma or karaya powder to the denuded area. This creates a dry surface to help the Calmoseptine® Ointment stick to the wound. Gently dust off excess powder.
- Gently place a layer of Calmoseptine® Ointment over the powdered area.
- Apply another light coating of the powder over the Calmoseptine® Ointment.
- It may be necessary to repeat, adding another layer of Calmoseptine® Ointment and powder in order to entirely cover the wound.
- Repeat after each bowel movement or diaper or dressing change. As in above applications, it is not necessary or advisable to remove all of the Calmoseptine® Ointment each time. Simply cleanse the surface and reapply the ointment where necessary.
How to Remove
- Wipe with a clean dry cloth or gauze. Skin or wound cleansers with surfactants may also be used. Baby oil (mineral oil) and vegetable oil are excellent for quick removal.
- If skin is tender or fragile, or if stoma powder has been used and the ointment is crusted, patting or rubbing with oil (mineral, vegetable, or baby oil) will soften the ointment for easier removal.
- Any residual can then be removed with soap and water or a skin or wound cleanser.
Some skin cleansers with a surfactant will remove Calmoseptine® Ointment. A few are listed below:
- Bedside Care Perineal Wash® (Sween/Coloplast)
- Elta Cleanse Foam®(Swiss America)
- Aloe Vesta Perineal Wash® (ConvatecCalgon Vestal)
- Carrington Foam® (Carrington Laboratories)
- Hygiene I Foam® (Bard)
- Proshield® Foam and Spray (Healthpoint)
- Restore® (Hollister)
For solid objects like floors, vinyl, wood etc. Use mineral or baby oil applied to a cotton ball, pat until the Calmoseptine® Ointment loosens enough to be removed with the cotton ball. Clean the oil.
Clorox® 2 has been found to be useful
For institutional situation or where reclaiming (all stained items are washed and cleaned together) is used, contact Anderson Chemical Company (phone: 320-693-2477) and ask about their product, Accent.
Allergic Reaction: Althought rare, the possibility of an allergic reaction is present if the patient is sensitive to any of the ingredients in Calmoseptine® Ointment. Common allergic reactions include itching, rash, or hives or increased area of rash compared to what was present in the area applied. As in any allergic reaction, more severe symtpoms such as extreme discomfort or difficulty breathing (anaphylaxis) could occur. If condition worsens or does not improve in 7 days, discontinue use and consult a doctor.
Note: if you suspect your patient is allergic, remove Calmoseptine® Ointment by one of the methods described above