NDC | 58301-181-28 |
Set ID | 9a6f173c-7dcf-4a1c-8817-486eeace753d |
Category | HUMAN OTC DRUG LABEL |
Packager | MBI Distributing Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
-
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
-
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