SPL v1
SPL
SPL Set ID 592c1f48-21c8-4ff5-8818-046662c9effe
Route
ORAL
Published
Effective Date 2025-11-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oyster Shell Calcium Carbonate, Crude (6 [hp_X]) Fluoride Ion (6 [hp_Q]) Calcium Cation Ferrosoferric Phosphate Potassium Cation Potassium Phosphate Carbonate Ion Phosphate Ion Chloride Ion Sodium Sulfate Anhydrous Sand
Inactive Ingredients
Water Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2025-11-19

Description

Calcium Carbonica 6X 7.14%               bone growth, teething* Calcium Fluoratum 6X 7.14%              connective tissue* Calcium Phosphoricum 6X 7.14%         skin healing, acne* Calcium Sulphuricum 6X 7.14%           metabolism, resilience* Ferrum Phosphoricum 6X 7.14%          inflammation, immunity* Kalium Muriaticum 6X 7.14%              congestion, eruptions* Kalium Phosphoricum 6X 7.14%          nerves, sleep* Kalium Sulphuricum 6X 7.14%            skin, respiration* Magnesium Carbonica 6X 7.14%          digestion, irritability* Magnesium Phosphoricum 6X 7.14%     cramps, spasms* Natrum Muriaticum 6X 7.14%               headaches, emotions* Natrum Phosphoricum 6X 7.14%          digestion, joints* Natrum Sulphuricum 6X 7.14%            liver, detox* Silicea 6X 7.14%                                 skin health, immunity* * Claims based on homeopathic practice are not accepted medical evidence. These claims have not been evaluated by the FDA.

Purpose

Calcium Carbonica 6X 7.14%               bone growth, teething* Calcium Fluoratum 6X 7.14%              connective tissue* Calcium Phosphoricum 6X 7.14%         skin healing, acne* Calcium Sulphuricum 6X 7.14%           metabolism, resilience* Ferrum Phosphoricum 6X 7.14%          inflammation, immunity* Kalium Muriaticum 6X 7.14%              congestion, eruptions* Kalium Phosphoricum 6X 7.14%          nerves, sleep* Kalium Sulphuricum 6X 7.14%            skin, respiration* Magnesium Carbonica 6X 7.14%          digestion, irritability* Magnesium Phosphoricum 6X 7.14%     cramps, spasms* Natrum Muriaticum 6X 7.14%               headaches, emotions* Natrum Phosphoricum 6X 7.14%          digestion, joints* Natrum Sulphuricum 6X 7.14%            liver, detox* Silicea 6X 7.14%                                 skin health, immunity* * Claims based on homeopathic practice are not accepted medical evidence. These claims have not been evaluated by the FDA.


Medication Information

Purpose

Calcium Carbonica 6X 7.14%               bone growth, teething* Calcium Fluoratum 6X 7.14%              connective tissue* Calcium Phosphoricum 6X 7.14%         skin healing, acne* Calcium Sulphuricum 6X 7.14%           metabolism, resilience* Ferrum Phosphoricum 6X 7.14%          inflammation, immunity* Kalium Muriaticum 6X 7.14%              congestion, eruptions* Kalium Phosphoricum 6X 7.14%          nerves, sleep* Kalium Sulphuricum 6X 7.14%            skin, respiration* Magnesium Carbonica 6X 7.14%          digestion, irritability* Magnesium Phosphoricum 6X 7.14%     cramps, spasms* Natrum Muriaticum 6X 7.14%               headaches, emotions* Natrum Phosphoricum 6X 7.14%          digestion, joints* Natrum Sulphuricum 6X 7.14%            liver, detox* Silicea 6X 7.14%                                 skin health, immunity* * Claims based on homeopathic practice are not accepted medical evidence. These claims have not been evaluated by the FDA.

Description

Calcium Carbonica 6X 7.14%               bone growth, teething* Calcium Fluoratum 6X 7.14%              connective tissue* Calcium Phosphoricum 6X 7.14%         skin healing, acne* Calcium Sulphuricum 6X 7.14%           metabolism, resilience* Ferrum Phosphoricum 6X 7.14%          inflammation, immunity* Kalium Muriaticum 6X 7.14%              congestion, eruptions* Kalium Phosphoricum 6X 7.14%          nerves, sleep* Kalium Sulphuricum 6X 7.14%            skin, respiration* Magnesium Carbonica 6X 7.14%          digestion, irritability* Magnesium Phosphoricum 6X 7.14%     cramps, spasms* Natrum Muriaticum 6X 7.14%               headaches, emotions* Natrum Phosphoricum 6X 7.14%          digestion, joints* Natrum Sulphuricum 6X 7.14%            liver, detox* Silicea 6X 7.14%                                 skin health, immunity* * Claims based on homeopathic practice are not accepted medical evidence. These claims have not been evaluated by the FDA.

Uses

Encourages healthy mineral levels and tissue repair during periods of stress, fatigue or recovery.

Section 50565-1

Section 55105-1

Warnings

For oral use only. If pregnant or breast-feeding, ask a health care professional before use. Keep out of the reach of children.

Directions

Adults take 1 dropper sublingually 2-4 times daily. Kids 12-17 years of age take ½ dropper 2-3 times daily.

Kids under 12, please consult with your healthcare provider.

Product Label

Inactive Ingredients

Organic Glycerin, Purified water

Questions Or Comments? 

Contact us for questions at (651)-273-3074-M-F, 9.00AM -5.00PM CST

Active Ingredients                              Purpose

Calcium Carbonica 6X 7.14%               bone growth, teething*

Calcium Fluoratum 6X 7.14%              connective tissue*

Calcium Phosphoricum 6X 7.14%         skin healing, acne*

Calcium Sulphuricum 6X 7.14%           metabolism, resilience*

Ferrum Phosphoricum 6X 7.14%          inflammation, immunity*

Kalium Muriaticum 6X 7.14%              congestion, eruptions*

Kalium Phosphoricum 6X 7.14%          nerves, sleep*

Kalium Sulphuricum 6X 7.14%            skin, respiration*

Magnesium Carbonica 6X 7.14%          digestion, irritability*

Magnesium Phosphoricum 6X 7.14%     cramps, spasms*

Natrum Muriaticum 6X 7.14%               headaches, emotions*

Natrum Phosphoricum 6X 7.14%          digestion, joints*

Natrum Sulphuricum 6X 7.14%            liver, detox*

Silicea 6X 7.14%                                 skin health, immunity*

* Claims based on homeopathic practice are not accepted medical evidence. These claims have not been evaluated by the FDA.


Structured Label Content

Uses

Encourages healthy mineral levels and tissue repair during periods of stress, fatigue or recovery.

Section 50565-1 (50565-1)

Section 55105-1 (55105-1)

Warnings

For oral use only. If pregnant or breast-feeding, ask a health care professional before use. Keep out of the reach of children.

Directions

Adults take 1 dropper sublingually 2-4 times daily. Kids 12-17 years of age take ½ dropper 2-3 times daily.

Kids under 12, please consult with your healthcare provider.

Product Label (Product label)

Inactive Ingredients (Inactive ingredients)

Organic Glycerin, Purified water

Questions Or Comments?  (QUESTIONS OR COMMENTS? )

Contact us for questions at (651)-273-3074-M-F, 9.00AM -5.00PM CST

Active Ingredients                              Purpose (Active ingredients                              Purpose)

Calcium Carbonica 6X 7.14%               bone growth, teething*

Calcium Fluoratum 6X 7.14%              connective tissue*

Calcium Phosphoricum 6X 7.14%         skin healing, acne*

Calcium Sulphuricum 6X 7.14%           metabolism, resilience*

Ferrum Phosphoricum 6X 7.14%          inflammation, immunity*

Kalium Muriaticum 6X 7.14%              congestion, eruptions*

Kalium Phosphoricum 6X 7.14%          nerves, sleep*

Kalium Sulphuricum 6X 7.14%            skin, respiration*

Magnesium Carbonica 6X 7.14%          digestion, irritability*

Magnesium Phosphoricum 6X 7.14%     cramps, spasms*

Natrum Muriaticum 6X 7.14%               headaches, emotions*

Natrum Phosphoricum 6X 7.14%          digestion, joints*

Natrum Sulphuricum 6X 7.14%            liver, detox*

Silicea 6X 7.14%                                 skin health, immunity*

* Claims based on homeopathic practice are not accepted medical evidence. These claims have not been evaluated by the FDA.


Advanced Ingredient Data


Raw Label Data

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