Oral Soothe: Homeopathic Product Information

ORAL SOOTHE — passiflora incarnata top, matricaria recutita, calcium fluoride, anhydrous dibasic calcium phosphate and matricaria recutita granule
Feelgood Health

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 and crying during teething

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

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

Caution: If symptoms persist or worsen, a health care professional should be consulted. Keep this and all medicines from the reach of children.

Ingredients: Each dose contains equal parts of Passiflora (3X) (HPUS), Chamomilla (3X) (HPUS), Calc fluor (6X) (HPUS), Calc phos (6X) (HPUS), Chamomilla (6C) (HPUS)

Sucrose (inactive ingredient).

Contains no gluten, artificial flavors, colors or preservatives.Safe for all ages.

All Native Remedies health products are especially 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

The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopoeia of the United States.

bottle label
(click image for full-size original)

Keep this and all medicines from the reach of children.

ORAL SOOTHE
passiflora, chamomilla, calc fluor, calc phos, chamomilla granule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68647-165
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PASSIFLORA INCARNATA TOP (PASSIFLORA INCARNATA TOP) PASSIFLORA INCARNATA TOP 3 [hp_X] in 40 mg
MATRICARIA RECUTITA (MATRICARIA RECUTITA) MATRICARIA RECUTITA 3 [hp_X] in 40 mg
CALCIUM FLUORIDE (CALCIUM CATION) CALCIUM FLUORIDE 6 [hp_X] in 40 mg
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (CALCIUM CATION) ANHYDROUS DIBASIC CALCIUM PHOSPHATE 6 [hp_X] in 40 mg
MATRICARIA RECUTITA (MATRICARIA RECUTITA) MATRICARIA RECUTITA 6 [hp_C] in 40 mg
Inactive Ingredients
Ingredient Name Strength
SUCROSE 20000 mg in 20000 mg
Product Characteristics
Color white (white sucrose granules) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68647-165-10 20000 mg in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 01/01/2010
Labeler — Feelgood Health (538418296)
Establishment
Name Address ID/FEI Operations
W. Last 567284153 manufacture

Revised: 08/2010 Feelgood Health

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