FDA Label for Aldamed
View Indications, Usage & Precautions
Aldamed Product Label
The following document was submitted to the FDA by the labeler of this product Herbamedicus, S.r.o.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Menthol 3%.....................Topical Analgesic
Otc - Purpose
Topical Analgesic
Use
Temporary relief of pain from sunburn, minor burns, bruises, and scrapes.
Warnings
For external use only. Keep away from heat or flame.
Do Not Use
directly on mucous membranes
on open skin wounds or burns
When Using This Product
do not use it in or near the eyes or mouth.
Otc - Ask Doctor
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
if irritation, itching, or rash occurs.
Keep Out Of Reach Of Children
If swallowed, get medical help, or contact a poison control center immediately at 1-800-222-1222.
Directions
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
Store in a cool, and dry place and avoid freezing and excessive heat
Do not expose the product to the direct sunlight
Inactive Ingredient
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
200 mL NDC: 82811-114-11
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