Drugplain

Ammonium Lactate 12 g/100g

Ammonium Lactate · CREAM · Padagis Israel Pharmaceuticals Ltd

No Recall History
Plain English

Ammonium Lactate is a cream containing ammonium lactate at 12 g/100g, taken topical. Manufactured by Padagis Israel Pharmaceuticals Ltd.

Key Facts

Brand Name
Ammonium Lactate
Generic Name
Ammonium Lactate
NDC Code (Product)
45802-493
Manufacturer
Padagis Israel Pharmaceuticals Ltd
Strength
12 g/100g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
ANDA075774
Drug Class
alpha-Hydroxy Acid [EPC]
Marketing Start
08/16/2006

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Ammonium Lactate Cream, 12% is indicated for the treatment of ichthyosis vulgaris and xerosis.

Dosage & Administration

DOSAGE AND ADMINISTRATION Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.

Warnings

WARNING Sun exposure to areas of the skin treated with Ammonium Lactate Cream, 12% should be minimized or avoided (see PRECAUTIONS section). The use of Ammonium Lactate Cream, 12% should be discontinued if any hypersensitivity is observed.

Contraindications

CONTRAINDICATIONS Ammonium Lactate Cream, 12% is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.

Adverse Reactions

ADVERSE REACTIONS In controlled clinical trials of patients with ichthyosis vulgaris, the most frequent adverse reactions in patients treated with Ammonium Lactate Cream, 12% were rash (including erythema and irritation) and burning/stinging. Each was reported in approximately 10 to 15% of patients. In addition, itching was reported in approximately 5% of patients. In controlled clinical trials of patients with xerosis, the most frequent adverse reactions in patients treated with Ammonium Lactate Cream, 12% were transient burning, in about 3% of patients, stinging, dry skin and rash, each reported in approximately 2% of patients.

Frequently Asked Questions

What is Ammonium Lactate used for?

Ammonium Lactate contains Ammonium Lactate. It is a cream taken topical. Consult your doctor for specific uses.

Is Ammonium Lactate a controlled substance?

Ammonium Lactate is not classified as a controlled substance by the DEA.

What is the generic name for Ammonium Lactate?

The generic name for Ammonium Lactate is Ammonium Lactate. There are no other listed brand versions of Ammonium Lactate.

What is the NDC code for Ammonium Lactate 12 g/100g?

The NDC (National Drug Code) for Ammonium Lactate 12 g/100g is 45802-493, listed by Padagis Israel Pharmaceuticals Ltd.

Product NDC

45802-493

Package NDC

45802-493-26

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)