SILICEA- silicea tablet, chewable 
HOMEOLAB USA 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.

----------

DRUGS FACTS

Active ingredients HPUS

Silicea (Silica) 12X

Purpose

...........................................Skin eruptions, brittle nails, dull hair

The letters 'HPUS' indicate that the component in this product is officially monographed in the Homoeopathic Pharmacopoeia of the United States.

Uses

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.

Warnings

Stop use and ask a doctor if symptoms persist for more than 7 days or worsen.

As with any drug, ask a doctor before use if pregnant or nursing.

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.

Directions

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.

Other information

Store at room temperature.

Do not use if cap seal is broken or missing.

Inactive ingredients

Lactose, magnesium stearate.

LABEL

image of label 125tabs

image of label 500tabs

SILICEA 
silicea tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-8034
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize8mm
FlavorImprint Code NONE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60512-8034-5125 in 1 JAR
2NDC:60512-8034-6500 in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/26/2014
Labeler - HOMEOLAB USA INC (202032533)
Establishment
NameAddressID/FEIBusiness Operations
HOMEOLAB USA INC202032533manufacture(60512-8034)

Revised: 3/2014
Document Id: cc338d30-14b0-4763-8e55-cac2c7521ae1
Set id: ac821284-e300-47c9-b3cb-882c3cb98bfc
Version: 1
Effective Time: 20140326
 
HOMEOLAB USA INC