Label: ADDICLENZ- boldo, carduus marianus, chelidonium majus, petroselinum sativum, taraxacum officinale, arsenicum album, bisphenol a, cobaltum metallicum, cuprum metallicum, glyphosate, iodium, lycopodium clavatum, phosphoricum acidum, selenium metallicum, zincum metallicum, aspartame, benzalkonium chloride, formalinum, methylene chloride, methyl paraben, propyl paraben, sodium benzoate, sodium citrate, titanium dioxide, zincum oxydatum liquid
- NDC Code(s): 43742-2055-1
- Packager: Deseret Biologicals, 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 October 31, 2024
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ACTIVE INGREDIENTS:
Arsenicum Album 12X, Aspartame 30X, Benzalkonium Chloride 30X, Bisphenol A 12X, Boldo 3X, Carduus Marianus 3X, Chelidonium Majus 3X, Cobaltum Metallicum 12X, Cuprum Metallicum 12X, Formalinum 30X, Glyphosate 12X, Iodium 12X, Lycopodium Clavatum 12X, Methylene Chloride 30X, Methyl Paraben 30X, Petroselinum Sativum 3X, Phosphoricum Acidum 12X, Propyl Paraben 30X, Selenium Metallicum 12X, Sodium Benzoate 30X, Sodium Citrate 30X, Taraxacum Officinale 3X, Titanium Dioxide 30X, Zincum Metallicum 12X, Zincum Oxydatum 30X.
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PURPOSE:
Arsenicum Album – Muscle Weakness, Aspartame - Headache, Benzalkonium Chloride – Skin Irritation, Bisphenol A – Liver Support, Boldo – Liver Support, Carduus Marianus – Skin Irritation, Chelidonium Majus – Poor Muscle Coordination, Cobaltum Metallicum – Muscle Weakness, Cuprum Metallicum - Headache, Formalinum - Headache, Glyphosate – Skin Irritation, Iodium – Muscle Weakness, Lycopodium Clavatum – Skin Irritation, Methylene Chloride – Poor Muscle Coordination, Methyl paraben – Skin Irritation, Petroselinum Sativum – Skin Irritation, Phosphoricum Acidum – Poor Muscle Coordination, Propylparaben – Liver Support, Selenium Metallicum – Muscle Weakness, Sodium Benzoate - Headache, Sodium Citrate – Skin Irritation, Taraxacum Officinale – Poor Muscle Coordination, Titanium Dioxide – Skin Irritation, Zincum Metallicum - Headache, Zincum Oxydatum – Skin Irritation.
- USES:
- WARNINGS:
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- INACTIVE INGREDIENTS:
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INGREDIENTS AND APPEARANCE
ADDICLENZ
boldo, carduus marianus, chelidonium majus, petroselinum sativum, taraxacum officinale, arsenicum album, bisphenol a, cobaltum metallicum, cuprum metallicum, glyphosate, iodium, lycopodium clavatum, phosphoricum acidum, selenium metallicum, zincum metallicum, aspartame, benzalkonium chloride, formalinum, methylene chloride, methyl paraben, propyl paraben, sodium benzoate, sodium citrate, titanium dioxide, zincum oxydatum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43742-2055 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O) (PEUMUS BOLDUS LEAF - UNII:Q4EWM09M3O) PEUMUS BOLDUS LEAF 3 [hp_X] in 1 mL MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE) MILK THISTLE 3 [hp_X] in 1 mL CHELIDONIUM MAJUS WHOLE (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS WHOLE 3 [hp_X] in 1 mL PETROSELINUM CRISPUM WHOLE (UNII: 1WZA4Y92EX) (PETROSELINUM CRISPUM - UNII:1WZA4Y92EX) PETROSELINUM CRISPUM WHOLE 3 [hp_X] in 1 mL TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE 3 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 12 [hp_X] in 1 mL BISPHENOL A (UNII: MLT3645I99) (BISPHENOL A - UNII:MLT3645I99) BISPHENOL A 12 [hp_X] in 1 mL COBALT (UNII: 3G0H8C9362) (COBALT - UNII:3G0H8C9362) COBALT 12 [hp_X] in 1 mL COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER 12 [hp_X] in 1 mL GLYPHOSATE (UNII: 4632WW1X5A) (GLYPHOSATE - UNII:4632WW1X5A) GLYPHOSATE 12 [hp_X] in 1 mL IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE 12 [hp_X] in 1 mL LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 12 [hp_X] in 1 mL PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID 12 [hp_X] in 1 mL SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM 12 [hp_X] in 1 mL ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 12 [hp_X] in 1 mL ASPARTAME (UNII: Z0H242BBR1) (ASPARTAME - UNII:Z0H242BBR1) ASPARTAME 30 [hp_X] in 1 mL BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 30 [hp_X] in 1 mL FORMALDEHYDE SOLUTION (UNII: T0H3L6C7I5) (FORMALDEHYDE SOLUTION - UNII:T0H3L6C7I5) FORMALDEHYDE SOLUTION 30 [hp_X] in 1 mL METHYLENE CHLORIDE (UNII: 588X2YUY0A) (METHYLENE CHLORIDE - UNII:588X2YUY0A) METHYLENE CHLORIDE 30 [hp_X] in 1 mL METHYLPARABEN (UNII: A2I8C7HI9T) (METHYLPARABEN - UNII:A2I8C7HI9T) METHYLPARABEN 30 [hp_X] in 1 mL PROPYLPARABEN (UNII: Z8IX2SC1OH) (PROPYLPARABEN - UNII:Z8IX2SC1OH) PROPYLPARABEN 30 [hp_X] in 1 mL SODIUM BENZOATE (UNII: OJ245FE5EU) (BENZOIC ACID - UNII:8SKN0B0MIM) SODIUM BENZOATE 30 [hp_X] in 1 mL SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) SODIUM CITRATE, UNSPECIFIED FORM 30 [hp_X] in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 30 [hp_X] in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 30 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43742-2055-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 05/09/2022 06/12/2029 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/09/2022 06/12/2029 Labeler - Deseret Biologicals, Inc. (940741853) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43742-2055) , api manufacture(43742-2055) , label(43742-2055) , pack(43742-2055)