Skin protectant

Manufacturer
CA-Botana International | Rodolfo Ugelstad
Effective date
2023-10-16
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-05-31 23:56:49

Label at a glance#

ProductSkin protectant
Active ingredientALUMINUM ACETATE
Label structure5 sections

Label contents#

Full prescribing information#

INACTIVE INGREDIENT SECTION

Cetyl Alcohol, Dimethico 100, Polyacrylic Acid, Polawax Polysorbate, Glycerin, Caprylyl Glycol, Ceramide NG, Water, Magnesium Aluminum Silicate, Glyceryl Stearate, Edenate Disodium, Tocopherol, Tetrahexyldecyl Ascorbate, Shea Butter, Phenoxyethanol, Strontium Nitrate, Xanthan Gum Hyaloronic acid, Stearyl Alcohol, IsopropyylMyrristate, Caprylic/Capric Tryglyceride

DOSAGE & ADMINISTRATION SECTION

use 3 times to[pically

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

For external use only Avoid contact with eyes Do not apply to open wound Stop use and ask a doctor if condition worsens or symtomps persist for more than seven days Keep out reach of children

label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dermaleve Cream Tube artwork.jpgDermaleve Cream Tube artwork.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
35192-029-052025-01-30C16284748780-12cef2736-83ac-d83d-e063-dadaa90ab31fDermaleve skin protectant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35192-029-05Skin protectant30 g in 1 TUBECREAM3011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35192-029SKIN PROTECTANT (ASTRIGENT) CREAM [CA-BOTANA INTERNATIONAL]11Legacy NDC, 1 package rows20231017_a1c983fb-c3ed-8730-e053-2a95a90a58bc.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35192-02935192-029-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
07da58c3-43a6-9d3a-e063-6394a90a3068a1c983fb-c3ed-8730-e053-2a95a90a58bc2023-10-16WarningsExact identifier
spl id: 07da58c3-43a6-9d3a-e063-6394a90a3068
spl set id: a1c983fb-c3ed-8730-e053-2a95a90a58bc

Reported adverse events (FAERS/openFDA)#

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