Label: BURN RELIEF- arsenic trioxide, atropa belladonna, lytta vesicatoria, causticum, picric acid, urtica urens, hypericum perforatum spray
- NDC Code(s): 43406-0631-2
- Packager: Natrural Creations, 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 December 19, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- KEEP OUT OF REACH OF CHILDREN
-
WARNINGS
WARNINGS:
- FOR EXTERNAL USE ONLY.
- Consult a physician for use in children under 12 years of age.
- IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
- KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
- Do no use if TAMPER EVIDENT seal is broken or missing.
- INACTIVE INGREDIENT
- QUESTIONS
- REFERENCES
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BURN RELIEF
arsenic trioxide, atropa belladonna, lytta vesicatoria, causticum, picric acid, urtica urens, hypericum perforatum sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43406-0631 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 30 [hp_C] in 1 mL Inactive Ingredients Ingredient Name Strength CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) CARBOMER 940 (UNII: 4Q93RCW27E) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43406-0631-2 60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 12/30/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/30/2016 Labeler - Natrural Creations, Inc. (018022074) Establishment Name Address ID/FEI Business Operations Ohm Pharma, Inc. 030572478 manufacture(43406-0631)