CROTAN Lotion Ref.[10049] Active ingredients:

If severe irritation or sensitization develops, treatment with this product should be discontinued and appropriate therapy instituted.

Primary inrritation reactions such as dermititis, pruritus and rash, and allergic sensitivity reactions have been reported in a few patients.

CROTAN lotion should not be applied in the eyes or mouth because it may cause irritation. It should not be applied to acutely inflamed skin or raw or weeping surfaces until acute inflammation has subsided.

Directions for patients with scrabies:

1. Take a routine bath or shower. Thoroughly massage CROTAN lotion into the skin from the chin to the toes including folds and creases.
2. Put CROTAN lotion under fingernails after trimming the fingernails short, because scabies are likely to remain there. A toothbrush can be used to apply the CROTAN lotion under the fingernails. Immediately after use, the toothbrush should be wrapped in paper and thrown away. Use of the brush in the mouth could lead to lead poisoning.
3. A second application is advisable 24 hours leater.
4. Clothing and bed linen should be changed the next day. Contaminated clothing and bed linen may be dry-cleaned or washed in the hot cycle of the washing machine.
5. A cleansing bath should be taken 48 hours after the last application.

None known.

Pregnancy (Category C).

Animal reproduction studies have not been conducted with CROTAN (crotamiton USP) lotion. It is also not known whether CROTAN can cause fetal harm when applied to a pregnant woman or can affect reproduction capacity. CROTAN should be given to a pregnant woman only if clearly needed.

Safety and effectiveness in children have not been established.

Clinical studies with CROTAN (crotamiton USP) lotion did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but great sensitivity of some older individuals cannot be ruled out.