Label: BURN AIDE- calendula officinalis, hypericum perforatum, arsenicum album, belladonna, cantharis, causticum, picricum acidum, urtica urens spray
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Contains inactivated NDC Code(s)
NDC Code(s): 43857-0472-1 - Packager: BioActive Nutritional, 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 August 28, 2019
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- ACTIVE INGREDIENTS:
- INDICATIONS:
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WARNINGS:
For external use only.
If pregnant or breast-feeding, ask a health care professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Do not use if tamper evident seal is broken or missing.
Store in cool, dry place.
Do not get in your eyes. If you get Burn Aide in your eyes, rinse immediately with cool tap water. In case of serious burns, consult a doctor. If your symptoms do not get better in seven days or if they get worse, check with your doctor.
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
BURN AIDE
calendula officinalis, hypericum perforatum, arsenicum album, belladonna, cantharis, causticum, picricum acidum, urtica urens sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0472 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X] in 1 mL HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 1 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 12 [hp_X] in 1 mL ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 12 [hp_X] in 1 mL LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA 12 [hp_X] in 1 mL CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM 12 [hp_X] in 1 mL PICRIC ACID (UNII: A49OS0F91S) (PICRIC ACID - UNII:A49OS0F91S) PICRIC ACID 12 [hp_X] in 1 mL URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS 12 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) BENZYL ALCOHOL (UNII: LKG8494WBH) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TOCOPHEROL (UNII: R0ZB2556P8) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SODIUM HYDROXIDE (UNII: 55X04QC32I) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43857-0472-1 120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 03/13/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/13/2018 Labeler - BioActive Nutritional, Inc. (624980496) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43857-0472) , api manufacture(43857-0472) , label(43857-0472) , pack(43857-0472)
