ORALSOOTHE  - calc fluor, calc phos, chamomilla, chamomilla, passiflora granule 
Native Remedies, LLC

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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OralSoothe

Relieves pain, crankiness & crying during teething

Active Ingredients: Each dose contains equal parts of: Calc fluor 8X HPUS, Calc phos 8X HPUS, Chamomilla 3X HPUS, Chamomilla 6C HPUS, Passiflora 3X HPUS.

Uses: Soothing homeopathic remedy for teething in babies and children.

Warnings: If symptoms persist or worsen, consult a healthcare professional.

If pregnant or breastfeeding, ask a health professional before use.

Keep this and all medication out of reach of children.

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

Directions: Babies:Sprinkle 1 pinch on the tongue when needed. Repeat after 20 minutes for up to 10 doses if needed.

Inactive Ingredients: Citric acid, corn starch, potassium sorbate, sucrose.

The letters HPUS indicate that the components in this products are officially monographed in the Homeopathic Pharmacopoeia of the United States.

All Native Remedies health products are specially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com

Distributed by
Native Remedies, LLC
6531 Park of Commerce Blvd.
Suite 160
Boca Raton, Fl 33487
Phone: 1.877.289.1235
International:+1.561.999.8857

Contains no artificial flavors or artificial colors. No gluten added.

Bottle Label

ORALSOOTHE  
calc fluor, calc phos, chamomilla, chamomilla, passiflora granule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-056
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE8 [hp_X]  in 16 mg
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) TRIBASIC CALCIUM PHOSPHATE8 [hp_X]  in 16 mg
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA3 [hp_X]  in 16 mg
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_C]  in 16 mg
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP3 [hp_X]  in 16 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
STARCH, CORN (UNII: O8232NY3SJ)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68703-056-2020000 mg in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/08/2013
Labeler - Native Remedies, LLC (192014186)
Establishment
NameAddressID/FEIBusiness Operations
King Bio617901350manufacture(68703-056) , api manufacture(68703-056)

Revised: 1/2013
Document Id: a7ce84ba-001a-4a0f-89a6-6f2689ccacbf
Set id: 8393be5c-a89a-4ca9-b2e5-44bcd5475194
Version: 1
Effective Time: 20130108
 
Native Remedies, LLC