DRUG FACTS

Drug Labeling and Warnings

Drug Details [pdf]

ADDICLENZ- beta vulgaris, boldo, petroselinum sativum, taraxacum officinale, arsenicum album, belladonna, cobaltum metallicum, cuprum metallicum, 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 
Deseret Biologicals, Inc.

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 FACTS

ACTIVE INGREDIENTS

Beta Vulgaris 3X, Boldo 3X, Petroselinum Sativum 3X, Taraxacum Officinale 3X, Arsenicum Album 12X, Belladonna 12X, Cobaltum Metallicum 12X, Cuprum Metallicum 12X, Iodium 12X, Lycopodium Clavatum 12X, Phosphoricum Acidum 12X, Selenium Metallicum 12X, Zincum Metallicum 12X, Aspartame 30X, Benzalkonium Chloride 30X, Formalinum 30X, Methylene Chloride 30X, Methyl Paraben 30X, Propyl Paraben 30X, Sodium Benzoate 30X, Sodium Citrate 30X, Titanium Dioxide 30X, Zincum Oxydatum 30X

INDICATIONS:

For temporary relief of symptoms related to food additives, herbicides and insecticides including muscle weakness, skin irritation, poor muscle coordination, headache, cough, diarrhea, dizziness, fatigue, fever, liver problems, pneumonia, stomach pain and vomiting.

WARNINGS:

Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away.

If pregnant or breast-feeding, seek advice of a health professional before use.

Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away.

DIRECTIONS:

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

For temporary relief of symptoms related to food additives, herbicides and insecticides including muscle weakness, skin irritation, poor muscle coordination, headache, cough, diarrhea, dizziness, fatigue, fever, liver problems, pneumonia, stomach pain and vomiting.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

Dist. By: Deseret Biologicals, Inc.

469 Parkland Drive

Sandy, UT 84070 www.desbio.com

*For complete list of Addisode contact Deseret Biologicals, Inc.

PACKAGE LABEL DISPLAY:

DESBIO

NDC: 43742-0494-1

HOMEOPATHIC

ADDICLENZ

1 FL OZ (30 ml)

Addiclenz

ADDICLENZ 
beta vulgaris, boldo, petroselinum sativum, taraxacum officinale, arsenicum album, belladonna, cobaltum metallicum, cuprum metallicum, 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
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43742-0494
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BETA VULGARIS (UNII: 4G174V5051) (BETA VULGARIS - UNII:4G174V5051) BETA VULGARIS3 [hp_X]  in 1 mL
PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O) (PEUMUS BOLDUS LEAF - UNII:Q4EWM09M3O) PEUMUS BOLDUS LEAF3 [hp_X]  in 1 mL
PETROSELINUM CRISPUM (UNII: 1WZA4Y92EX) (PETROSELINUM CRISPUM - UNII:1WZA4Y92EX) PETROSELINUM CRISPUM3 [hp_X]  in 1 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE3 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [hp_X]  in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA12 [hp_X]  in 1 mL
COBALT (UNII: 3G0H8C9362) (COBALT - UNII:3G0H8C9362) COBALT12 [hp_X]  in 1 mL
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER12 [hp_X]  in 1 mL
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE12 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 1 mL
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID12 [hp_X]  in 1 mL
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM12 [hp_X]  in 1 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC12 [hp_X]  in 1 mL
ASPARTAME (UNII: Z0H242BBR1) (ASPARTAME - UNII:Z0H242BBR1) ASPARTAME30 [hp_X]  in 1 mL
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE30 [hp_X]  in 1 mL
FORMALDEHYDE (UNII: 1HG84L3525) (FORMALDEHYDE - UNII:1HG84L3525) FORMALDEHYDE30 [hp_X]  in 1 mL
METHYLENE CHLORIDE (UNII: 588X2YUY0A) (METHYLENE CHLORIDE - UNII:588X2YUY0A) METHYLENE CHLORIDE30 [hp_X]  in 1 mL
METHYLPARABEN (UNII: A2I8C7HI9T) (METHYLPARABEN - UNII:A2I8C7HI9T) METHYLPARABEN30 [hp_X]  in 1 mL
PROPYLPARABEN (UNII: Z8IX2SC1OH) (PROPYLPARABEN - UNII:Z8IX2SC1OH) PROPYLPARABEN30 [hp_X]  in 1 mL
SODIUM BENZOATE (UNII: OJ245FE5EU) (BENZOIC ACID - UNII:8SKN0B0MIM) SODIUM BENZOATE30 [hp_X]  in 1 mL
SODIUM CITRATE (UNII: 1Q73Q2JULR) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) SODIUM CITRATE30 [hp_X]  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE30 [hp_X]  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION30 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43742-0494-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/22/201408/12/2019
Labeler - Deseret Biologicals, Inc. (940741853)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43742-0494) , api manufacture(43742-0494) , label(43742-0494) , pack(43742-0494)

Revised: 10/2015