FDA Label for Burn
View Indications, Usage & Precautions
Burn Product Label
The following document was submitted to the FDA by the labeler of this product Mbi Distributing Inc.. 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.
Otc - Active Ingredient
Aesculus hippocastanum 4x, Aloe socotrina 4x, Arnica montana 4x, Berberis vulgaris 4x, Calendula officinalis 4x, Salicylicum acidum 2x, Zincum metallicum 3x
Inactive Ingredient
deionized water, propylene glycol, polysorbate 20, glycerine, sodium bicarbonate, MSM, Dimethylaminoethanol, citric acid, potassium sorbate, benzyl alcohol, trace minerals (trona), avocado oil, and vitamin E
Indications & Usage
Temporarily relieves symptoms of minor burns, superficial scalds, sunburn, and other minor skin irritations such as:
- redness
- stinging
- burning
- itching
- minor pain
- dryness
- as per homeopathic materia medica
Dosage & Administration
Directions
- Adults and children 3 years of age and older:
- clean the burned area(s)
- apply topically as needed not more than 12 times daily
- area may be covered with a sterile bandage
- children under 3 years of age: consult a physician
Otc - Purpose
Aesculus hippocastanum...................................................Venous Stasis
Aloe socotrina...........................................................................Redness
Arnica montana...........................................................................Burning
Berberis vulgaris..........................................................................Burning
Calendula officinalis.....................................................................Healing
Salicylicum acidum.......................................................Burning and Heat
Zincum metallicum.............................................................Pain Reliever
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Warnings
For external use only.
Otc - Questions
Questions?1.800.321.3740Mon-Fri, 9am-5pm
Package Label.Principal Display Panel
Otc - Do Not Use
Do not
- use if you are allergic to salicylates (although this product does not contain aspirin)
- use in the eyes
- apply over large areas of the body
- use longer than 1 week unless directed by a doctor
- ingest
Otc - Ask Doctor
Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns.
Otc - When Using
When using this product
- use only as directed
- test on a small area before use. This product may cause allergic reaction in some individuals.
- wash hands before and after using
- avoid contact with eyes or mucous membranes
- do not bandage tightly
Otc - Stop Use
Stop use and ask a doctor if
- condition worsens
- if symptoms persist for more than 7 days or clear up and occur again within a few days
- excessive skin irritation occurs
Storage And Handling
- store at room temperature
- Tamper Evident: Do not use if imprinted seal around cap is broken or missing.
* Please review the disclaimer below.