ORAL SOOTHE - passiflora, chamomilla, calc fluor, calc phos, chamomilla 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.

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ORALSOOTHE

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

Keep this and all medicines from the reach of children.

ORAL SOOTHE 
passiflora, chamomilla, calc fluor, calc phos, chamomilla granule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68647-165
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PASSIFLORA INCARNATA TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA TOP3 [hp_X]  in 40 mg
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA3 [hp_X]  in 40 mg
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM FLUORIDE6 [hp_X]  in 40 mg
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) (CALCIUM CATION - UNII:2M83C4R6ZB) ANHYDROUS DIBASIC CALCIUM PHOSPHATE6 [hp_X]  in 40 mg
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_C]  in 40 mg
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554) 20000 mg  in 20000 mg
Product Characteristics
Colorwhite (white sucrose granules) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68647-165-1020000 mg in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/01/2010
Labeler - Feelgood Health (538418296)
Establishment
NameAddressID/FEIBusiness Operations
W. Last567284153manufacture

Revised: 8/2010
Document Id: 4d3ab8fa-4961-4dd0-8361-e7c92e3bb5f6
Set id: 016b8e20-b260-44cc-a851-6ade29e60488
Version: 4
Effective Time: 20100827
 
Feelgood Health