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 Green Idea 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
Camphor 3% ….……………………………………………………………………..…..Topical Analgesic, Topical Antitussive
Menthol 2% …...…………………..…………………..………………………………...Topical Analgesic, Topical Antitussive
Eucalyptus Oil 1%...........................................................................................................................................Topical Antitussive
Otc - Purpose
on chest and throat, temporarily relieves cough due to common cold
Use
Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, simple backache, bruises, strains, and sprains.
Warnings
For external use only. Avoid contact with eyes.
Do not heat, microwave, or add to hot water or any container heating water. This may result in splatter and skin burns.
When Using This Product
Do not take
by mouth or place in nostrils
on wounds or damaged skin or with tight bandages
Otc - Ask Doctor
Ask a doctor before use if you
have a cough that occurs with excessive phlegm (mucus)
have persistent or chronic cough such as occurs with smoking, asthma or emphysema
are pregnant, or breastfeeding
Stop Use And Ask A Doctor
the cough persists for more than seven days, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a severe condition.
Keep Out Of Reach Of Children
If swallowed, get medical help, or contact a poison control center immediately at 1-800-222-1222.
Directions
for adults & children two years of age and over:
rub a thick layer on the chest and throat or rub on aching muscles, and cover with a warm, dry cloth if desired.
keep clothing loose about the throat/chest to help vapors reach the nose/mouth
repeat up to three times per 24 hours or as directed by a doctor
for children under two years of age: consult a doctor
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
amyris balsamifera bark oil
arctium lappa root extract
butyrospermum parkii butter
cedrus deodara wood oil
cera alba
cocos nucifera oil
chamomilla recutita (matricaria) flower extract
cupressus sempervirents oil
eugenia caryophyllus leaf oil
helianthus annuus seed oil
hyssopus officinalis herb oil
juniperus communis fruit oil
macadamia integrifolia seed oil
mentha piperita oil
pinus pumila twig leaf oil
pinus sylvestris twig leaf oil (pine needle oil)
prunus amygdalus dulcis oil (almond oil)
rosmarinus officinalis leaf oil
salix alba bark extract
thymus vulgaris oil
tocopheryl acetate - Alpha-tocopherol acetate
Package Label.Principal Display Panel
125 mL NDC: 82810-115-11
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