Salicylic acid has been shown to be teratogenic in rats and monkeys. It is difficult to extrapolate from oral doses of acetylsalicylic acid used in these studies to topical administration as the oral dose to monkeys may represent six times the maximal daily human dose of salicylic acid when applied topically over a large body surface. There are no adequate and well-controlled studies in pregnant women. Salex ® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Because of the potential for serious adverse reactions in nursing infants from the mother’s use of Salex ® , a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If used by nursing mothers, it should not be used on the chest area to avoid the accidental contamination of the child.
No data are available concerning potential carcinogenic or reproductive effects of Salex ®. Salicylic acid has been shown to lack mutagenic potential in the Ames Salmonella test.
Excessive erythema and scaling conceivably could result from use on open skin lesions.
The preferable method of use is to apply Salex ® thoroughly to the affected area and to cover the treated area at night after washing and before retiring. Preferably, the skin should be hydrated for at least five minutes prior to application. The medication is washed off in the morning and if excessive drying and/or irritation is observed, a bland cream or lotion may be applied. Once clearing is apparent, the occasional use of Salex ® will usually maintain the remission. In those areas where occlusion is difficult or impossible, application may be made more frequently; hydration by wet packs or baths prior to application apparently enhances the effect (See WARNINGS). Unless hands are being treated, hands should be rinsed thoroughly after application. Excessive repeated application of Salex ® will not necessarily increase its therapeutic benefit, but could result in increased local intolerance and systemic adverse effects such as salicylism.
Salex ® Cream is available in a 454 g (16 oz.) jar — NDC 0295-1040-36
Salex ® Lotion is available in a 8 fl. oz. (237 mL) bottle — NDC 0295-1039-28
Store at controlled room temperature
20° to 25°C (68° to 77°F). Do not freeze.
(1) Data on file.
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA
Denison Pharmaceuticals, LLC
Lincoln, RI 02865 USA
PATENT NO. 6,709,663
Salex ® Cream: 13548-010-17
Salex ® Lotion: 13548-011-09
Salex is a registered trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.
MVE is a trademark of DFB TECHNOLOGY, LTD.
Any other product/brand names are trademarks of their respective owners.
©Valeant Pharmaceuticals North America LLC
(6% Salicylic Acid)
For Topical Use Only
- 1 jar of
Salex ® Cream
– Net Wt. 454 g (16 oz.)
Bonus: 1 bottle of CeraVe® Hydrating Cleanser
– 12 fl. oz.
PATENTED MULTIVESICULAR EMULSION TM
| SALEX CREAM |
salicylic acid cream
|Labeler — Denison Pharmaceuticals, LLC (001207208)|
|Denison Pharmaceuticals, LLC||001207208||manufacture (0295-1040)|
Revised: 02/2019 Denison Pharmaceuticals, LLC
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.