BURN- aesculus hippocastanum, aloe socotrina, arnica montana, berberis vulgaris, calendula officinalis, salicylicum acidum, zincum metallicum spray

Burn by

Drug Labeling and Warnings

Burn by is a Homeopathic medication manufactured, distributed, or labeled by MBI Distributing Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
  

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

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.

QUESTIONS

Questions?

1.800.321.3740
Mon-Fri, 9am-5pm

PRINCIPAL DISPLAY PANEL

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
  

ASK DOCTOR

Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns.

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
  

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.
  

INGREDIENTS AND APPEARANCE

BURN 
aesculus hippocastanum, aloe socotrina, arnica montana, berberis vulgaris, calendula officinalis, salicylicum acidum, zincum metallicum spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58301-181
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M)	AESCULUS HIPPOCASTANUM FLOWER	4 [hp_X]  in 60 mL
ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9)	ALOE	4 [hp_X]  in 60 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	4 [hp_X]  in 60 mL
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U)	BERBERIS VULGARIS ROOT BARK	4 [hp_X]  in 60 mL
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	4 [hp_X]  in 60 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 [hp_X]  in 60 mL
ZINC SULFATE HEPTAHYDRATE (UNII: N57JI2K7WP) (ZINC CATION - UNII:13S1S8SF37)	ZINC SULFATE HEPTAHYDRATE	3 [hp_X]  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
BENZYL ALCOHOL (UNII: LKG8494WBH)
AVOCADO OIL (UNII: 6VNO72PFC1)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58301-181-28	60 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/01/2010

Labeler - MBI Distributing Inc. (196786545)

Registrant - MBI Distributing Inc. (196786545)

Establishment
Name	Address	ID/FEI	Business Operations
MBI Distributing Inc.		196786545	manufacture