Salicylic Acid (Page 2 of 2)

CONTRAINDICATIONS

Salicylic Acid 6% should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients.

Salicylic Acid 6% should not be used in children under 2 years of age.

WARNINGS

Prolonged use over large areas, especially in children and those patients with significant renal or hepatic impairment could result in salicylism. Concomitant use of other drugs which may contribute to elevated serum salicylate levels should be avoided where the potential for toxicity is present. In children under 12 years of age and those patients with renal or hepatic impairment, the area to be treated should be limited and the patient monitored closely for signs of salicylate toxicity: nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnea, diarrhea, and psychic disturbances. In the event of salicylic acid toxicity, the use of Salicylic Acid 6% should be discontinued. Fluids should be administered to promote urinary excretion. Treatment with sodium bicarbonate (oral or intravenous) should be instituted as appropriate.

Patients should be cautioned against the use of oral aspirin and other salicylate containing medications, such as sports injury creams, to avoid additional excessive exposure to salicylic acid.

Where needed, aspirin should be replaced by an alternative non-steroidal anti-inflammatory agent that is not salicylate based.

Patients should be advised not to apply occlusive dressings, clothing or other occlusive topical products such as petrolatum-based ointments to prevent excessive systemic exposure to salicylic acid. Excessive application of the product other than what is needed to cover the affected area will not result in a more rapid therapeutic benefit.

Due to potential risk of developing Reye’s syndrome, salicylate products should not be used in children and teenagers with varicella or influenza, unless directed by physician.

PRECAUTIONS

FOR EXTERNAL USE ONLY. Avoid contact with eyes and other mucous membranes.

DRUG INTERACTIONS

The following interactions are from a published review and include reports concerning both oral and topical salicylate administration. The relationship of these interactions to the use of Salicylic Acid 6% is not known.

PREGNANCY

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% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

NURSING MOTHERS

Nursing Mothers: Because of the potential for serious adverse reactions in nursing infants from the mother’s use of Salicylic Acid 6%, 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 accidental contamination of the child.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

Carcinogenesis, Mutagenesis, Impairment of Fertility: No data are available concerning potential carcinogenic or reproductive effects of Salicylic Acid 6%. It has been shown to lack mutagenic potential in the Ames test.

ADVERSE REACTIONS

Excessive erythema and scaling conceivably could result from use on open skin lesions. Call your physician for medical advice about side effects.

OVERDOSAGE

OVERDOSAGE See Warnings.

DOSAGE AND ADMINISTRATION

The preferable method of use is to apply Salicylic Acid 6% 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 a 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% 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% 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% Cream is available in 16 oz (454 g) bottles, NDC 42937-711-16

Salicylic Acid 6% Lotion is available in 16 fl. oz (473 mL) bottles, NDC 42937-712-16 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. Protect from freezing.

Manufactured for:

Manufactured for:
Nationwide Laboratories, LLC.
Iselin, New Jersey 08830

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SALICYLIC ACID
salicylic acid lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42937-712
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 6 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
Ammonium Lactate
Cetyl Alcohol
Dimethicone
EDETATE DISODIUM
Glycerin
GLYCERYL MONOSTEARATE
METHYLPARABEN
Mineral Oil
PEG-100 STEARATE
PHENOXYETHANOL
POLYSORBATE 80
PROPYLPARABEN
TROLAMINE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42937-712-16 473 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/06/2017
Labeler — Nationwide Laboratories, LLC (078366153)

Revised: 06/2017 Nationwide Laboratories, LLC

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