Salex Cream (Page 2 of 2)

Pregnancy (Category C)

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.

Nursing Mothers

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

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.

ADVERSE REACTIONS

Excessive erythema and scaling conceivably could result from use on open skin lesions.

OVERDOSAGE

See Warnings.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

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.

Manufactured for:

Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA
by:
Denison Pharmaceuticals, LLC
Lincoln, RI 02865 USA

PATENT NO. 6,709,663

REORDER NO.
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

9497700

70011485

PRINCIPAL DISPLAY PANEL — 454 g Carton

NDC 0295-1040-36

Rx only

Salex ®
(6% Salicylic Acid)
Cream


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

VALEANT

label
(click image for full-size original)
SALEX CREAM
salicylic acid cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0295-1040
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 60 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
AMMONIUM LACTATE
BEHENTRIMONIUM METHOSULFATE
CETOSTEARYL ALCOHOL
CETYL ALCOHOL
DIMETHICONE 350
EDETATE DISODIUM
GLYCERIN
GLYCERYL MONOSTEARATE
METHYLPARABEN
MINERAL OIL
PEG-100 STEARATE
PHENOXYETHANOL
PROPYLPARABEN
WATER
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0295-1040-36 454 g in 1 JAR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/26/2019
Labeler — Denison Pharmaceuticals, LLC (001207208)
Establishment
Name Address ID/FEI Operations
Denison Pharmaceuticals, LLC 001207208 manufacture (0295-1040)

Revised: 02/2019 Denison Pharmaceuticals, LLC

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