Label: SILICEA- silicon dioxide tablet, chewable
- NDC Code(s): 60512-8034-5, 60512-8034-6
- Packager: HOMEOLAB USA INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredients HPUS
Silicea (Silica) 12XClose
...........................................Skin eruptions, brittle nails, dull hairClose
The letters 'HPUS' indicate that the component in this product is officially monographed in the Homoeopathic Pharmacopoeia of the United States.Close
This tissue salt helps relieve symptoms associated with skin eruptions and irritations, brittle, splitting nails and dull, brittle hair.*
*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.Close
Keep this and all medications out of the reach of children.
In case of emergency or accidental overdose, contact a medical professional or a Poison Control Center immediately.
Children from 2 to 5 years: Crush 2 tablets and dissolve in water 3 times daily, or as directed by a healthcare professional.
Adults and children over 5 years: Chew 2 tablets 3 times daily, or as directed by a healthcare professional.
• Do not use more than directed.
• Do not take with food.Close
- Other information
Store at room temperature.
Do not use if cap seal is broken or missing.Close
- Inactive ingredients
Lactose, magnesium stearate.Close
- INGREDIENTS AND APPEARANCE
silicea tablet, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60512-8034 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 12 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score no score Shape ROUND Size 8mm Flavor Imprint Code NONE Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60512-8034-5 125 in 1 JAR 2 NDC:60512-8034-6 500 in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/26/2014 Labeler - HOMEOLAB USA INC (202032533) Establishment Name Address ID/FEI Business Operations HOMEOLAB USA INC 202032533 manufacture(60512-8034)