Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID aea99daf-7de4-4c85-b2b6-735ef095af2e
Route
ORAL
Published
Effective Date 2024-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aesculus Hippocastanum (horse Chestnut) Extract (6 [hp_X]) Equisetum Hyemale (8 [hp_X]) Goldenseal (6 [hp_C]) Centella Asiatica Flax Seed Magnesium Cation Passiflora Incarnata Flowering Top Solidago Virgaurea Flowering Top Thuja Occidentalis Leafy Twig Fumaria Officinalis Flower/leaf/stem Extract Ononis Campestris
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-11-08

Description

(in each spray) Aesculus Hippocastanum 6X 9.09%, Equisetum Hyemale 6X 9.09%, Hydrastis Canadensis 6X 9.09%, Hydrocotyle Asiatica 6X 9.09%, Linum Usitatissimum 6X 9.09%, Magnesia Muriatica 6X 9.09%, Passiflora Incarnata 6X 9.09%, Solidago Virgaurea 6X 9.09%, Thuja Occidentalis 6X 9.09%, Fumaria Officinalis 8X 9.09%, Ononis Spinosa 6C 9.09%.

Purpose

Aesculus Hippocastanum – Detox of colon, portal system,* Equisetum Hyemale – bladder, kidneys,* Hydrastis Canadensis – sinuses, lungs,* Hydrocotyle Asiatica – lymph, skin, connective tissue,** Linum Usitatissimum – mucous membranes,* Magnesia Muriatica - liver,* Passiflora Incarnata – nervous system,* Solidago Virgaurea – bladder, kidneys,* Thuja Occidentalis – intestines, skin,* Fumaria Officinalis – liver, gallbladder,* Ononis Spinosa – urinary system* *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Aesculus Hippocastanum – Detox of colon, portal system,* Equisetum Hyemale – bladder, kidneys,* Hydrastis Canadensis – sinuses, lungs,* Hydrocotyle Asiatica – lymph, skin, connective tissue,** Linum Usitatissimum – mucous membranes,* Magnesia Muriatica - liver,* Passiflora Incarnata – nervous system,* Solidago Virgaurea – bladder, kidneys,* Thuja Occidentalis – intestines, skin,* Fumaria Officinalis – liver, gallbladder,* Ononis Spinosa – urinary system* *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

(in each spray) Aesculus Hippocastanum 6X 9.09%, Equisetum Hyemale 6X 9.09%, Hydrastis Canadensis 6X 9.09%, Hydrocotyle Asiatica 6X 9.09%, Linum Usitatissimum 6X 9.09%, Magnesia Muriatica 6X 9.09%, Passiflora Incarnata 6X 9.09%, Solidago Virgaurea 6X 9.09%, Thuja Occidentalis 6X 9.09%, Fumaria Officinalis 8X 9.09%, Ononis Spinosa 6C 9.09%.

Uses:

May temporarily relieve symptoms of general toxicity such as fatigue, increased mucus, abdominal bloating, constipation alternating with diarrhea, skin conditions, muscle stiffness, soreness, pain.*

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Purpose:

Aesculus Hippocastanum – Detox of colon, portal system,* Equisetum Hyemale – bladder, kidneys,* Hydrastis Canadensis – sinuses, lungs,* Hydrocotyle Asiatica – lymph, skin, connective tissue,** Linum Usitatissimum – mucous membranes,* Magnesia Muriatica - liver,* Passiflora Incarnata – nervous system,* Solidago Virgaurea – bladder, kidneys,* Thuja Occidentalis – intestines, skin,* Fumaria Officinalis – liver, gallbladder,* Ononis Spinosa – urinary system*

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings:

For oral 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

Questions:

Dist. by Ratis, LLC

1201 N Orange St,

Ste 7594

Wilmington, DE 19801

AnnaKare.com

(888) 405-7551

Directions:

Adults: 4 sprays in mouth or water morning and evening.

Children under 12: 1 spray as above

Consult a physician for use in children under 12 years of age.

Store in a cool, dry place.

Active Ingredient:

(in each spray) Aesculus Hippocastanum 6X 9.09%, Equisetum Hyemale 6X 9.09%, Hydrastis Canadensis 6X 9.09%, Hydrocotyle Asiatica 6X 9.09%, Linum Usitatissimum 6X 9.09%, Magnesia Muriatica 6X 9.09%, Passiflora Incarnata 6X 9.09%, Solidago Virgaurea 6X 9.09%, Thuja Occidentalis 6X 9.09%, Fumaria Officinalis 8X 9.09%, Ononis Spinosa 6C 9.09%.

Inactive Ingredients:

Demineralized water, organic ethanol 20%

Package Label Display:

LACTOSE FREE

ANNA KARE

Klean Detox

DETOX OF ELIMINATION CENTERS

HOMEOPATHIC ORAL SPRAY

1FL OZ (30ML)

Keep Out of Reach of Children:

In case of overdose, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses: (USES:)

May temporarily relieve symptoms of general toxicity such as fatigue, increased mucus, abdominal bloating, constipation alternating with diarrhea, skin conditions, muscle stiffness, soreness, pain.*

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Purpose: (PURPOSE:)

Aesculus Hippocastanum – Detox of colon, portal system,* Equisetum Hyemale – bladder, kidneys,* Hydrastis Canadensis – sinuses, lungs,* Hydrocotyle Asiatica – lymph, skin, connective tissue,** Linum Usitatissimum – mucous membranes,* Magnesia Muriatica - liver,* Passiflora Incarnata – nervous system,* Solidago Virgaurea – bladder, kidneys,* Thuja Occidentalis – intestines, skin,* Fumaria Officinalis – liver, gallbladder,* Ononis Spinosa – urinary system*

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings: (WARNINGS:)

For oral 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

Questions: (QUESTIONS:)

Dist. by Ratis, LLC

1201 N Orange St,

Ste 7594

Wilmington, DE 19801

AnnaKare.com

(888) 405-7551

Directions: (DIRECTIONS:)

Adults: 4 sprays in mouth or water morning and evening.

Children under 12: 1 spray as above

Consult a physician for use in children under 12 years of age.

Store in a cool, dry place.

Active Ingredient: (ACTIVE INGREDIENT:)

(in each spray) Aesculus Hippocastanum 6X 9.09%, Equisetum Hyemale 6X 9.09%, Hydrastis Canadensis 6X 9.09%, Hydrocotyle Asiatica 6X 9.09%, Linum Usitatissimum 6X 9.09%, Magnesia Muriatica 6X 9.09%, Passiflora Incarnata 6X 9.09%, Solidago Virgaurea 6X 9.09%, Thuja Occidentalis 6X 9.09%, Fumaria Officinalis 8X 9.09%, Ononis Spinosa 6C 9.09%.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, organic ethanol 20%

Package Label Display: (PACKAGE LABEL DISPLAY:)

LACTOSE FREE

ANNA KARE

Klean Detox

DETOX OF ELIMINATION CENTERS

HOMEOPATHIC ORAL SPRAY

1FL OZ (30ML)

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

In case of overdose, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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