Label: BURN- aesculus hippocastanum, aloe socotrina, arnica montana, berberis vulgaris, calendula officinalis, salicylicum acidum, zincum metallicum spray
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Contains inactivated NDC Code(s)
NDC Code(s): 58301-181-28 - Packager: MBI Distributing Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated July 28, 2011
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
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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
- WARNINGS
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
- DO NOT USE
- ASK DOCTOR
- WHEN USING
- STOP USE
- STORAGE AND HANDLING
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INGREDIENTS AND APPEARANCE
BURN
aesculus hippocastanum, aloe socotrina, arnica montana, berberis vulgaris, calendula officinalis, salicylicum acidum, zincum metallicum sprayProduct 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