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Ammonium Lactate

Prescription ANDA TE AB Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Ammonium Lactate
Generic name
Ammonium Lactate
Dosage form
Lotion
Route
Topical
Marketing category
ANDA · ANDA
Labeler
Bryant Ranch Prepack
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
6
Packages
9
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Ammonium Lactate 12 g/100g 543460 View
Ammonium Lactate 120 mg/g 543460 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Lotion
Route of administration
Topical
Presentations
15

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Acidifying Activity [MoA] MoA All 14 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
075570
Application type
ANDA · Abbreviated New Drug Application
Approval date
June 23, 2004
Sponsor
PADAGIS ISRAEL
Products on application
1
Submissions recorded
2
Products approved under application 075570.
Product Trade name Form Strength Ingredient Status TE Flags
075570-001 AMMONIUM LACTATE LOTION AMMONIUM LACTATE Prescription AB RS

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
No
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 075570.
Type No. Action Status Date Review
Supplement 1 Labeling Approved June 9, 2009 —
Original application 1 Approved June 23, 2004 —

Review documents

  • 0 · Original application · April 20, 2006

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260730). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN PRESCRIPTION DRUG · 20260730 HUMAN PRESCRIPTION DRUG · 20240208 HUMAN PRESCRIPTION DRUG · 20230717

Indications and Usage

openFDA Drug Labeling

INDICATIONS AND USAGE Ammonium Lactate Lotion, 12% is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris, and for the temporary relief of itching associated with these conditions.

Dosage and Administration

openFDA Drug Labeling

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

Contraindications

openFDA Drug Labeling

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

Warnings

openFDA Drug Labeling

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

Adverse Reactions

openFDA Drug Labeling

ADVERSE REACTIONS The most frequent adverse experiences in patients with xerosis are transient stinging (1 in 30 patients), burning (1 in 30 patients), erythema (1 in 50 patients) and peeling (1 in 60 patients). Other adverse reactions which occur less frequently are irritation, eczema, petechiae, dryness and hyperpigmentation. Due to the more severe initial skin conditions associated with ichthyosis, there was a higher incidence of transient stinging, burning and erythema (each occurring in 1 in 10 patients). To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Description

openFDA Drug Labeling

DESCRIPTION *Ammonium Lactate Lotion, 12% specially formulates 12% lactic acid, as ammonium lactate to provide a lotion pH of 4.5 to 5.5. Ammonium Lactate Lotion also contains cetyl alcohol, glycerin, glyceryl monostearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methylparaben, polyoxyethylene 100 stearate, polyoxyl stearate type II, propylene glycol, propylparaben, purified water, and for pH adjustment: lactic acid. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula: Chemical Structure

Overdosage

openFDA Drug Labeling

OVERDOSAGE The oral administration of Ammonium Lactate Lotion to rats and mice showed this drug to be practically non-toxic (LD 50 >15 mL/kg).

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Ammonium Lactate Lotion, 12% is available as follows: NDC: 72162-1407-4: 400 g in a BOTTLE, PLASTIC NDC: 72162-1407-2: 225 g in a BOTTLE, PLASTIC STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Adverse event reports

Source: openFDA FAERS
2,119
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: AMMONIUM LACTATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
50090-6587-0 50090-6587 A-S Medication Solutions 225 g in 1 BOTTLE, PLASTIC (50090-6587-0) August 10, 2023
63629-8610-1 63629-8610 Bryant Ranch Prepack 225 g in 1 BOTTLE, PLASTIC (63629-8610-1) June 20, 2006
63629-8611-1 63629-8611 Bryant Ranch Prepack 400 g in 1 BOTTLE, PLASTIC (63629-8611-1) June 20, 2006
72162-1407-2 72162-1407 Bryant Ranch Prepack 225 g in 1 BOTTLE, PLASTIC (72162-1407-2) February 8, 2024
72162-1407-4 72162-1407 Bryant Ranch Prepack 400 g in 1 BOTTLE, PLASTIC (72162-1407-4) February 8, 2024
45802-419-26 45802-419 Padagis Israel Pharmaceuticals Ltd 400 g in 1 BOTTLE, PLASTIC (45802-419-26) June 20, 2006
45802-419-54 45802-419 Padagis Israel Pharmaceuticals Ltd 225 g in 1 BOTTLE, PLASTIC (45802-419-54) June 20, 2006
51672-1300-5 51672-1300 Sun Pharmaceutical Industries, Inc. 225 g in 1 BOTTLE, PLASTIC (51672-1300-5) May 28, 2004
51672-1300-9 51672-1300 Sun Pharmaceutical Industries, Inc. 400 g in 1 BOTTLE, PLASTIC (51672-1300-9) May 28, 2004
50090-6587 50090-6587 A-S Medication Solutions — May 28, 2004
63629-8610 63629-8610 Bryant Ranch Prepack — June 20, 2006
63629-8611 63629-8611 Bryant Ranch Prepack — June 20, 2006
72162-1407 72162-1407 Bryant Ranch Prepack — June 20, 2006
45802-419 45802-419 Padagis Israel Pharmaceuticals Ltd — June 20, 2006
51672-1300 51672-1300 Sun Pharmaceutical Industries, Inc. — May 28, 2004

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 12 sections on this page.