Ammonium Lactate

Padagis Israel Pharmaceuticals Ltd
Human Prescription Drug
NDC 45802-419

Ammonium Lactate is a human prescription drug labeled by 'Padagis Israel Pharmaceuticals Ltd'. National Drug Code (NDC) number for Ammonium Lactate is 45802-419. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Ammonium Lactate drug includes Ammonium Lactate - 12 g/100g . The currest status of Ammonium Lactate drug is Active.

Drug Information:

Drug NDC:	45802-419
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Ammonium Lactate
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Ammonium Lactate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Padagis Israel Pharmaceuticals Ltd
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Lotion
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	AMMONIUM LACTATE - 12 g/100g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	20 Jun, 2006
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	28 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	ANDA075570
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Padagis Israel Pharmaceuticals Ltd
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	197362
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	N0000175842 M0010745
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	67M901L9NQ
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:	alpha-Hydroxy Acid [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class CS:	Hydroxy Acids [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Acidifying Activity [MoA]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
45802-419-26	400 g in 1 BOTTLE, PLASTIC (45802-419-26)	20 Jun, 2006	N/A	No
45802-419-54	225 g in 1 BOTTLE, PLASTIC (45802-419-54)	20 Jun, 2006	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Product Elements:

Ammonium lactate ammonium lactate ammonium lactate lactic acid cetyl alcohol glycerin glyceryl monostearate laureth-4 light mineral oil magnesium aluminum silicate methylcellulose (400 mpa.s) methylparaben peg-100 stearate polyoxyl 40 stearate propylene glycol propylparaben water

Indications and Usage:

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.

Warnings:

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.

General Precautions:

General - for external use only. stinging or burning may occur when applied to skin with fissures, erosions, or that is otherwise abraded (for example, after shaving the legs). caution is advised when used on the face because of the potential for irritation. the potential for post-inflammatory hypo- or hyperpigmentation has not been studied.

Dosage and Administration:

Dosage and administration shake well. apply to the affected areas and rub in thoroughly. use twice daily or as directed by a physician.

Contraindications:

Contraindications ammonium lactate lotion, 12% is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.

Adverse Reactions:

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).

Use in Pregnancy:

Pregnancy: teratogenic effects: pregnancy category b â animal reproduction studies have been performed in rats and rabbits at doses up to 0.7 and 1.5 times the human dose, respectively (600 mg/kg/day, corresponding to 3600 mg/m 2 /day in the rat and 7200 mg/m 2 /day in the rabbit) and have revealed no evidence of impaired fertility or harm to the fetus due to ammonium lactate formulations. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, ammonium lactate lotion, 12% should be used during pregnancy only if clearly needed.

Pediatric Use:

Pediatric use - safety and effectiveness of ammonium lactate have been demonstrated in infants and children. no unusual toxic effects were reported.

Geriatric Use:

Geriatric use - clinical studies of ammonium lactate lotion, 12% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between elderly and younger patients. in general, dose selection for an elderly patient should be cautious.

Overdosage:

Overdosage the oral administration of ammonium lactate to rats and mice showed this drug to be practically non-toxic (ld 50 >15 ml/kg).

Description:

Description *ammonium lactate lotion, 12% specially formulates 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate to provide a lotion ph of 4.5 - 5.5. it also contains cetyl alcohol, fragrance, glycerin, glyceryl stearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methylparaben, peg-100 stearate, polyoxyl 40 stearate, propylene glycol, propylparaben, and purified water. lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula: structural formula

Clinical Pharmacology:

Clinical pharmacology lactic acid is an alpha-hydroxy acid, it is a normal constituent of tissues and blood. the alpha-hydroxy acids (and their salts) may act as humectants when applied to the skin. this property may influence hydration of the stratum corneum. in addition, lactic acid, when applied to the skin, may act to decrease corneocyte cohesion. the mechanism(s) by which this is accomplished is not yet known. an in vitro study of percutaneous absorption of ammonium lactate lotion, 12% using human cadaver skin indicates that approximately 5.8% of the material was absorbed after 68 hours.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility - the topical treatment of cd-1 mice with 12%, 21% or 30% ammonium lactate formulations for two-years did not produce a significant increase in dermal or systemic tumors in the absence of increased exposure to ultraviolet radiation. the maximum systemic exposure of the mice in this study was 0.7 times the maximum possible systemic exposure in humans. however, a long-term photocarcinogenicity study in hairless albino mice suggested that topically applied 12% ammonium lactate formulations enhanced the rate of ultraviolet light-induced skin tumor formation. the mutagenic potential of ammonium lactate formulations was evaluated in the ames assay and in the mouse in vivo micronucleus assay, both of which were negative. in dermal segment i and iii studies with ammonium lactate formulations there were no effects observed in fertility or pre- or postnatal development parameters in rats at dose levels of 300 mg/kg/day (1800 mg/m 2 /day), appr Read more...

oximately 0.4 times the human topical dose.

How Supplied:

How supplied ammonium lactate lotion, 12% is available as follows: 225 g bottle (ndc 45802- 419 -54) 400 g bottle (ndc 45802- 419 -26) storage store at 20-25Â°c (68-77Â°f) [see usp controlled room temperature].

Information for Patients:

Information for patients patients using ammonium lactate lotion, 12% should receive the following information and instructions: 1. this medication is to be used as directed by the physician, and should not be used for any disorder other than for which it was prescribed. it is for external use only. avoid contact with eyes, lips, or mucous membranes. 2. patients should minimize or avoid use of this product on areas of the skin that may be exposed to natural or artificial sunlight, including the face. if sun exposure is unavoidable, clothing should be worn to protect the skin. 3. this medication may cause transient stinging or burning when applied to skin with fissures, erosions, or abrasions (for example, after shaving the legs). 4. if the skin condition worsens with treatment, the medication should be promptly discontinued.

Package Label Principal Display Panel:

Principal display panel rx only ndc 45802- 419 -26 ammonium lactate lotion, 12%* net wt 400 g contains: *ammonium lactate equivalent to 12% lactic acid, cetyl alcohol, fragrance, glycerin, glyceryl stearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methylparaben, peg-100 stearate, polyoxyl 40 stearate, propylene glycol, propylparaben, and purified water. usual dosage: shake well. apply to the affected areas and rub in thoroughly. use twice daily or as directed by a physician. keep out of reach of children. store at 20-25Â°c (68-77Â°f) [see usp controlled room temperature]. for lot number and expiration date, see bottle. manufactured by padagis, minneapolis, mn 55427 2204341 rev 12-21 a 33pa7 rc f2 the following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. label serialization-template.jpg

Comments/ Reviews:

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