Ammonium Lactate 12% Cream

Manufacturer
IPG PHARMACEUTICALS INC
Effective date
2025-02-21
Label type
COSMETIC
Version
1
Source
full-release
Hydrated at
2026-06-01 02:51:28

Label at a glance#

ProductAmmonium Lactate 12% Cream
Label structure2 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Description: Moisturizing body 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 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 an doctor.

Ingredients: Water, Lactic Acid, Mineral Oil, Glyceryl Stearate, PEG-100, Stearate, Cetyl Alcohol, Glycerin, Ammonium Hydroxide, Propylene Glycol, Laureth-4, Magnesium Aluminum Silicate, PEG-40 Stearate, Methylcellulose, Methylparaben, Propylparaben.

Other information (if applicable)

CAUTION: For external use only. Keep out of reach of children. Avoid contact with eyes, lips and mucus membranes. Irritation may occur when used on the face. A mild irritation or rash may occur on sensitive skin with initial use. This product may cause transient stinging when applied to skin with abrasions or fissures. If irritation or rash persists, discontinue use and contact a doctor. Avoid unnecessary exposure to the sun and use a sunscreen.

Do not use on children under 2 years of age. Read package insert carefully. Flammable. Keep away from heat and open flame.

Keep this and all medications out of reach of children.

Store at controlled room temperature 59° to 86° F
(15° to 30° C).

Questions or comments?
Call 1-888-711-7116

Manufactured for:
IPG Pharmaceuticals, Inc.
Tempe, AZ 85281

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

image descriptionimage description

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
00371085072030Ammonium Lactate 12% Cream145 g in 1 PACKAGE1451
00371085072047Ammonium Lactate 12% Cream285 g in 1 PACKAGE2851

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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.