Aldamed

Manufacturer
Green Idea s.r.o.
Effective date
2023-11-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:20:32

Label at a glance#

ProductAldamed
Active ingredientMENTHOL
Label structure13 sections

Dosage and administration

apply on the affected area and rub gently till absorbed. Apply up to 3 times daily. do no use on children below the age of 3 years old

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 3%.....................Topical Analgesic

OTC - PURPOSE SECTION

Topical Analgesic

Use

INDICATIONS & USAGE SECTION

Temporary relief of pain from sunburn, minor burns, bruises, and scrapes.

warnings

WARNINGS SECTION

For external use only. Keep away from heat or flame.

Do not use

OTC - DO NOT USE SECTION

directly on mucous membranes

on open skin wounds or burns

When using this product

OTC - WHEN USING SECTION

do not use it in or near the eyes or mouth.

OTC - ASK DOCTOR SECTION

if pregnant or if you have a cough associated with smoking, excessive phlegm, asthma, emphysema, or persistent or chronic cough.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation, itching, or rash occurs.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help, or contact a poison control center immediately at 1-800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

apply on the affected area and rub gently till absorbed. Apply up to 3 times daily.

do no use on children below the age of 3 years old

Other information

OTHER SAFETY INFORMATION

Store in a cool, and dry place and avoid freezing and excessive heat

Do not expose the product to the direct sunlight

Inactive ingredient

INACTIVE INGREDIENT SECTION

Aqua, glycerin, biosacharide gum-1, polysorbate 80, prunus amygdalus dulcis oil, carbomer, phenoxyethanol, ethylhexylglycerin, panthenol, hippophae rhamnoides fruit extract, rosmarinus officinalis leaf extract, simmondsia chinensis seed oil, calendula officinalis flower extract, menthol 0,3%, beta-glucan, sodium hydroxide, rosa canina fruit oil, aloe barbadensis leaf juice, tocopheryl acetate, persea gratissima oil, hydrogenated palm glycerides, butyrospermum parkii butter, lavandula officinalis flower extract, arnica montana flower extract, hypericum perforatum extract, melissa officinalis flower/leaf/stem extract, camellia sinensis flower extract, centella asiatica extract, vaccinium myrtillus fruit extract, vitis vinifera seed oil, chamomilla recutita flower extract, hamamelis virginiana leaf extract, macadamia ternifolia seed oil, babassu oil glycereth-8 esters, prunus armeniaca kernel oil, D&C orange no 4.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SundermiaSundermia200 mL NDC: 82810-114-11

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82810-114-112024-01-30C16284748780-11030e365-02d9-111a-e063-dadaa90a10e2Green Idea-Herbamedicus Sundermia

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82810-11482810-114-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 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
1e0ef10a-c0c0-b2f0-e063-6394a90a8004e805bb51-c98d-caf5-e053-2a95a90aeeea2024-07-25WarningsExact identifier
spl set id: e805bb51-c98d-caf5-e053-2a95a90aeeea

Reported adverse events (FAERS/openFDA)#

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