Ammonium Lactate
Bryant Ranch Prepack
Human Prescription Drug
NDC 63629-8609Ammonium Lactate is a human prescription drug labeled by 'Bryant Ranch Prepack'. National Drug Code (NDC) number for Ammonium Lactate is 63629-8609. This drug is available in dosage form of Cream. 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: | 63629-8609 |
| 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: | Bryant Ranch Prepack |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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: | 16 Aug, 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: | ANDA075774 |
| 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: | Bryant Ranch Prepack
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 543460
|
| 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. |
| 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 |
|---|
| 63629-8609-1 | 385 g in 1 BOTTLE, PUMP (63629-8609-1) | 19 Feb, 2007 | 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. |
Product Elements:
Ammonium lactate ammonium lactate ammonium lactate lactic acid cetyl alcohol glycerin glyceryl monostearate light mineral oil magnesium aluminum silicate methylparaben peg-100 stearate polyoxyl 40 stearate propylene glycol propylparaben water laureth-4 ammonium lactate cream structural formula
Indications and Usage:
Indications and usage ammonium lactate cream, 12% is indicated for the treatment of ichthyosis vulgaris and xerosis.
Warnings:
Warning sun exposure to areas of the skin treated with ammonium lactate cream, 12% should be minimized or avoided (see precautions ). use of this product should be discontinued if hypersensitivity to any of the ingredients is noted.
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 apply to the affected areas and rub in thoroughly. use twice daily or as directed by a physician.
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 were rash (including erythema and irritation) and burning/stinging. each was reported in approximately 10-15% 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 were transient burning, in about 3% of patients, stinging, dry skin and rash, each reported in approximately 2% of patients.
Use in Pregnancy:
Pregnancy: teratogenic effects: pregnancy category b - 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 cream. 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 cream should be used during pregnancy only if clearly needed.
Pediatric Use:
Pediatric use - the safety and efficacy of ammonium lactate cream, 12% has been established in patients as young as 2 years old.
Description:
Description *ammonium lactate cream, 12% is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a ph of 4.4 - 5.4. ammonium lactate cream, 12% also contains cetyl alcohol, 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:
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) are felt to 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 cream using human cadaver skin indicates that approximately 6.1% 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 cream enhanced the rate of ultraviolet light-induced skin tumor formation. the mutagenic potential of ammonium lactate cream 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 cream, there were no effects observed in fertility or pre- or post-natal development parameters in rats at dose levels of 300 mg/kg/day (1800 mg/m 2 /day), approximately 0.4 times
Read more... the human topical dose.
How Supplied:
How supplied ammonium lactate cream, 12% is available as follows: 385 g bottle (ndc 63629-8609-1) storage store at 20-25°c (68-77°f) [see usp controlled room temperature].
Information for Patients:
Information for patients patients using ammonium lactate cream, 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 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:
Ammonium lactate 12% cream, #385 label