S-Caine is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.

S-Caine should only be applied to intact skin.

For use in adults only.

· For superficial dermatological procedures such as dermal filler injection or facial laser ablation, apply S-Caine to intact skin for 20-30 minutes prior to the procedure.

· For superficial dermatological procedures such as laser-assisted tattoo removal, apply S-Caine to intact skin for 60 minutes prior to the procedure.

The dose of S-Caine that provides effective local dermal analgesia depends on the duration of the application. Although not specifically studied, a shorter duration of application may result in a less complete dermal analgesia or a shorter duration of adequate dermal analgesia.

The amount (length) of study drug that should be dispensed is determined by the size of the area to be treated (see Table 3). Squeeze out and measure the amount of S-Caine that approximates the amount required to achieve proper coverage. Then spread S-Caine evenly and thinly (approximately 1 mm or the thickness of a dime) across the treatment area using a flat-surfaced tool such as a metal spatula or tongue depressor. After waiting the required application time, remove the S-Caine by grasping a free-edge with your fingers and pulling it away from the skin.

If skin irritation or a burning sensation occurs during application, remove S-Caine.

Hands should be washed after handling S-Caine, and eye contact with S-Caine should be avoided. Access to S-Caine by children or pets should be prevented during usage and storage of the product.

Used S-Caine tubes should be disposed of immediately. Discard used S-Caine in a location that prevents accidental ingestion by children or pets.

S-Caine (lidocaine and tetracaine) 7%/7% cream is available as the following:

NDC yyyy-yyyy-yy 30 gram tube

Store in a refrigerator, temperature 2-8° C (36-46° F). Do not freeze.

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