Salicylic Acid (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. Salicylic Acid 6% (w/w) Cream 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 Salicylic Acid 6% (w/w) Cream, 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 is available concerning potential carcinogenic or reproductive effects of Salicylic Acid 6% (w/w) Cream. Salicylic acid has been shown to lack mutagenic potential in the Ames Salmonella test.

Adverse Reactions to Salicylic Acid

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 6% Salicylic Acid (w/w) Cream 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 Salicylic Acid 6% (w/w) Cream 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 Salicylic Acid 6% (w/w) Cream will not necessarily increase its therapeutic benefit, but could result in increased local intolerance and systemic adverse effects such as salicylism.

HOW SUPPLIED

Salicylic Acid 6% (w/w) Cream Kit includes a 16 oz. (454 g) jar with Salicylic Acid 6% (w/w) Cream (NDC 42546-270-16) as well as a complimentary 12 fl. oz. PruDrate Hydrating Cleanser.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized.

Do not freeze.

Manufactured for:
PruGen Pharmaceuticals
18899 N Thompson Peak Pkwy
Scottsdale, AZ 85255
Rev 3.0

PRINCIPAL DISPLAY PANEL — Kit Box

NDC 42546-270-01
Rx Only

Salicylic Acid
6% Cream
Kit

Dispense as a complete kit
For Topical Use Only

Kit includes:

• 1 jar of Salicylic Acid 6% Cream
  — Net Wt. 16 oz (454 g)
• 1 bottle PruDrate Hydrating Cleanser
  — 12 fl oz (355 mL)
• Package Insert

PRUGEN ^®
PHARMACEUTICALS

Established Pharmacological Class

Substance Pharmacological Class PruDrate Hydrating Cleanser CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, AND PADS)

SALICYLIC ACID salicylic acid kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42546-270

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42546-270-01 1 KIT in 1 BOX None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 JAR 454 g Part 2 1 BOTTLE 355 g

Part 1 of 2 SALICYLIC ACID salicylic acid cream

Product Information 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 CETOSTEARYL ALCOHOL PEG-3 DISTEAROYLAMIDOETHYLMONIUM METHOSULFATE POLYSORBATE 60 CETYL ALCOHOL DIMETHICONE 350 EDETATE DISODIUM GLYCERIN GLYCERYL STEARATE SE METHYLPARABEN MINERAL OIL PEG-100 STEARATE PHENOXYETHANOL PROPYLPARABEN WATER TROLAMINE

Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 454 g in 1 JAR None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 05/01/2011

Part 2 of 2 PRUDRATE HYDRATING CLEANSER hydrating cleanser solution

Product Information Route of Administration TOPICAL DEA Schedule

Ingredients Ingredient Name Quantity WATER SODIUM LAURETH-3 SULFATE COCAMIDOPROPYL BETAINE GLYCERIN COCO MONOETHANOLAMIDE SODIUM LAUROYL SARCOSINATE GLYCERYL MONOSTEARATE PEG-100 STEARATE CETYL ALCOHOL JOJOBA OIL POLYSORBATE 80 PHENOXYETHANOL ETHYLHEXYLGLYCERIN LEVOMENOL MEDIUM-CHAIN TRIGLYCERIDES XANTHAN GUM SALICYLIC ACID

Packaging # Item Code Package Description Multilevel Packaging 1 355 g in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 05/01/2011

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 05/01/2011

Labeler — PruGen, Inc. (929922750)

Establishment
Name	Address	ID/FEI	Operations
DERMAZONE SOLUTIONS, INC.		136116865	MANUFACTURE (42546-270)

Revised: 01/2022 PruGen, Inc.