FDA.reportPublic FDA data

MEDPURA Ammonium Lactate Cream

Manufacturer
Akron Pharma Inc.
Effective date
2024-11-30
Label type
COSMETIC
Version
1
Source
full-release
Hydrated at
2026-06-01 02:51:17

Label at a glance#

ProductMEDPURA Ammonium Lactate Cream
Label structure2 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Description: Ammonium Lactate 12% Moisturizing Cream helps hydrate, soften and exfoliate dry, rough skin. This skin smoothing cream is specially formulated with 12% lactic acid neutralized with ammonium hydroxide for a pH of 4.5 - 5.5.
Lactic acid is an alpha hydroxy acid and a natural humectant for the skin.
Directions: For best results, apply to dry skin twice a day, or as directed by a doctor.
Caution: For external use only. Keep out of reach of children. Avoid contact with the eyes, lips and mucus membranes. Irritation
may occur when used on the face. If irritation or sensitivity occurs, discontinue use.

Ingredients: Ammonium Hydroxide Solution, Cetyl Alcohol, Glycerin, GMS & PEG 100 Stearate, Hydroxyethyl Cellulose, Lactic Acid,
Light Mineral Oil, Magnesium Aluminum Silicate, Methyl Paraben, PEG 40 Hydrogenated Castor oil, Propylene Glycol, Propyl Paraben, PurifiedWater, 2-dodecoxyethanol (Laureth-4).

Other information: Store at 68°- 77°F (20°- 25°C).
Avoid excessive heat.
For lot number and expiration date, see crimp of the tube
Questions or comments? Please call 1 (877) 225-6999

Manufactured for:

Akron Pharma, Inc.
Fairfield, NJ-07004
www.akronphanna.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CreamCream

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
371399049445MEDPURA Ammonium Lactate Cream140 g in 1 PACKAGE1401

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMMONIUM LACTATE67M901L9NQINGR
CETYL ALCOHOL936JST6JCNINGR
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947INGR
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DINGR
LACTIC ACID33X04XA5ATINGR
MINERAL OILT5L8T28FGPINGR
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCINGR
METHYLPARABENA2I8C7HI9TINGR
PEG-40HAF0412YITINGR
HYDROGENATED CASTOR OILZF94AP8MEYINGR
PROPYLENE GLYCOL6DC9Q167V3INGR
PROPYLPARABENZ8IX2SC1OHINGR
WATER059QF0KO0RINGR
LAURETH-46HQ855798JINGR

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ammonium lactateAMMONIUM LACTATEZydus Lifesciences Limited10a894e6-d23a-4142-8c9f-7bf96be9b9912026-10-02Name fallback
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATESun Pharmaceutical Industries, Inc.9745b6ce-f532-4e80-b6e9-477ab9db4e302026-08-17Warnings, Adverse reactionsName fallback
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATESun Pharmaceutical Industries, Inc.8bb09bb3-5bbc-489d-96c1-ae97cb58381e2026-07-30Warnings, Adverse reactionsName fallback
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEREMEDYREPACK INC.030e8bd1-0ff3-479f-aa77-16fab701a1112026-04-14Warnings, Adverse reactionsName fallback
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEPadagis Israel Pharmaceuticals Ltd7096d38e-2bd1-4374-9bf6-7fd09ef7509c2025-11-30Warnings, Adverse reactionsName fallback
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEPadagis Israel Pharmaceuticals Ltddc3a6462-0f2c-4306-b5ef-c7b47395e9592025-06-30Warnings, Adverse reactionsName fallback
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEBryant Ranch Prepack170f8764-a180-49fa-b406-44f5b7921a662024-04-12Warnings, Adverse reactionsName fallback
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEBryant Ranch Prepack99a5db95-7b48-46f1-99c7-db1c9ea656812024-02-08Warnings, Adverse reactionsName fallback
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEA-S Medication Solutionsab54704d-ace2-410c-b0af-2fa13462a8b32023-08-24Warnings, Adverse reactionsName fallback
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEBryant Ranch Prepack411b40c7-4d62-4ea4-be69-bea5d1d591ca2023-08-16Warnings, Adverse reactionsName fallback
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEBryant Ranch Prepack1d2adae5-0225-4e66-8f4f-14a5ef11e1d02023-07-17Warnings, Adverse reactionsName fallback
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEBryant Ranch Prepack2455f1aa-562d-424a-9542-4853adf1ca752023-07-17Warnings, Adverse reactionsName fallback
generic name: AMMONIUM LACTATE
Ammonium LactateAMMONIUM LACTATEBryant Ranch Prepack7a23d405-a48c-482f-9b28-6ae851ccefe32023-07-17Warnings, Adverse reactionsName fallback
generic name: AMMONIUM LACTATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.