OralSoothe: Homeopathic Product Information

ORALSOOTHE — calcium fluoride, tribasic calcium phosphate, matricaria recutita, matricaria recutita and passiflora incarnata flowering top 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.

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
(click image for full-size original)

ORALSOOTHE
calc fluor, calc phos, chamomilla, chamomilla, passiflora granule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68703-056
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM FLUORIDE (FLUORIDE ION) CALCIUM FLUORIDE 8 [hp_X] in 16 mg
TRIBASIC CALCIUM PHOSPHATE (CALCIUM CATION) TRIBASIC CALCIUM PHOSPHATE 8 [hp_X] in 16 mg
MATRICARIA RECUTITA (MATRICARIA RECUTITA) MATRICARIA RECUTITA 3 [hp_X] in 16 mg
MATRICARIA RECUTITA (MATRICARIA RECUTITA) MATRICARIA RECUTITA 6 [hp_C] in 16 mg
PASSIFLORA INCARNATA FLOWERING TOP (PASSIFLORA INCARNATA FLOWERING TOP) PASSIFLORA INCARNATA FLOWERING TOP 3 [hp_X] in 16 mg
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
STARCH, CORN
POTASSIUM SORBATE
SUCROSE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68703-056-20 20000 mg in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 01/08/2013
Labeler — Native Remedies, LLC (192014186)
Establishment
Name Address ID/FEI Operations
King Bio 617901350 manufacture (68703-056), api manufacture (68703-056)

Revised: 01/2013 Native Remedies, LLC

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