CANDIDA - YEAST- adrenalinum, candida albicans, thyroidinum, torula cerevisiae, triticum, ustilago maidis, antimon. crud, arsenicum alb., baptisia, berber. aqui., bryonia, calc. phos., cinchona, helonias dioica, hydrastis, iodium, iris versicolor, kali carb., lachesis, lycopodium, merc. viv., nat.carb., nat. phos, nitricum ac., phosphorus, podoph. pelt, pulsatilla, sepia, echinacea, ginkgo, juglans regia, lappa, thuja occ. liquid
Newton Laboratories, 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.

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Candida 2230L-Dis

INDICATIONS & USAGE SECTION

Candida - Yeast Formulated for associated symptoms such as poor digestion, gas, bloating, fatigue, mental fogginess, itching and discharge.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Adrenalinum 15x, Candida albicans15x, Thyroidinum 15x, Torula cerevisiae 15x, Triticum 15x, Ustilagomaidis 15x, Antimon. crud. 10x, Arsenicum alb. 10x, Baptisia 10x,Berber. aqui. 10x, Bryonia 10x, Calc. phos. 10x, Cinchona 10x,Helonias dioica 10x, Hydrastis 10x, Iodium 10x, Iris versicolor 10x,Kali carb. 10x, Lachesis 10x, Lycopodium 10x, Merc. viv. 10x, Nat.carb. 10x, Nat. phos. 10x, Nitricum ac. 10x, Phosphorus 10x,Podoph. pelt. 10x, Pulsatilla 10x, Sepia 10x, Echinacea 3x, Ginkgo3x, Juglans regia 3x, Lappa 3x, Thuja occ. 3x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as poor digestion, gas, bloating, fatigue, mental fogginess, itching and discharge.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%

QUESTIONS SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

PACKAGE LABEL

CANDIDA - YEAST
adrenalinum, candida albicans, thyroidinum, torula cerevisiae, triticum, ustilago maidis, antimon. crud, arsenicum alb., baptisia, berber. aqui., bryonia, calc. phos., cinchona, helonias dioica, hydrastis, iodium, iris versicolor, kali carb., lachesis, lycopodium, merc. viv., nat.carb., nat. phos, nitricum ac., phosphorus, podoph. pelt, pulsatilla, sepia, echinacea, ginkgo, juglans regia, lappa, thuja occ. liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-2230
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	15 [hp_X] in 1 mL
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC)	CANDIDA ALBICANS	15 [hp_X] in 1 mL
THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P) (THYROID, UNSPECIFIED - UNII:0B4FDL9I6P)	THYROID, UNSPECIFIED	15 [hp_X] in 1 mL
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) (SACCHAROMYCES CEREVISIAE - UNII:978D8U419H)	SACCHAROMYCES CEREVISIAE	15 [hp_X] in 1 mL
ELYMUS REPENS ROOT (UNII: 3IXW0F6P8W) (ELYMUS REPENS ROOT - UNII:3IXW0F6P8W)	ELYMUS REPENS ROOT	15 [hp_X] in 1 mL
USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (USTILAGO MAYDIS - UNII:4K7Z7K7SWG)	USTILAGO MAYDIS	15 [hp_X] in 1 mL
ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U)	ANTIMONY TRISULFIDE	10 [hp_X] in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	10 [hp_X] in 1 mL
BAPTISIA TINCTORIA (UNII: 5K1UO2888Y) (BAPTISIA TINCTORIA - UNII:5K1UO2888Y)	BAPTISIA TINCTORIA	10 [hp_X] in 1 mL
MAHONIA AQUIFOLIUM ROOT BARK (UNII: VZJ9F3C3SB) (MAHONIA AQUIFOLIUM ROOT BARK - UNII:VZJ9F3C3SB)	MAHONIA AQUIFOLIUM ROOT BARK	10 [hp_X] in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	10 [hp_X] in 1 mL
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR)	TRIBASIC CALCIUM PHOSPHATE	10 [hp_X] in 1 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	10 [hp_X] in 1 mL
CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U)	CHAMAELIRIUM LUTEUM ROOT	10 [hp_X] in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	10 [hp_X] in 1 mL
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	10 [hp_X] in 1 mL
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC)	IRIS VERSICOLOR ROOT	10 [hp_X] in 1 mL
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D)	POTASSIUM CARBONATE	10 [hp_X] in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	10 [hp_X] in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	10 [hp_X] in 1 mL
MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL)	MERCURY	10 [hp_X] in 1 mL
SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D)	SODIUM CARBONATE	10 [hp_X] in 1 mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	10 [hp_X] in 1 mL
NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4)	NITRIC ACID	10 [hp_X] in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	10 [hp_X] in 1 mL
PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3)	PODOPHYLLUM	10 [hp_X] in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	10 [hp_X] in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	10 [hp_X] in 1 mL
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	3 [hp_X] in 1 mL
GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T)	GINKGO	3 [hp_X] in 1 mL
ENGLISH WALNUT (UNII: 1V3SHR7QB7) (ENGLISH WALNUT - UNII:1V3SHR7QB7)	ENGLISH WALNUT	3 [hp_X] in 1 mL
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3)	ARCTIUM LAPPA ROOT	3 [hp_X] in 1 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	3 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55714-2230-1	29.57 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	03/01/2011	01/31/2019
2	NDC:55714-2230-2	59.14 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	03/01/2011	01/31/2019
3	NDC:55714-2230-0	0.5 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	03/01/2011	01/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/01/2011	01/31/2019

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	manufacture(55714-2230)

Revised: 1/2019

Document Id: 910c1a4c-c545-04c1-e053-2995a90a9cd9

Set id: 99a08d45-4faa-57bb-335e-58a365dcf35c

Version: 3

Effective Time: 20190131

Newton Laboratories, Inc.