GENTLE NATURALS- matricaria recutita, tribasic calcium phosphate, potassium phosphate, dibasic, magnesium phosphate, dibasic trihydrate, and delphinium staphisagria seed liquid

Gentle Naturals by

Drug Labeling and Warnings

Gentle Naturals by is a Homeopathic medication manufactured, distributed, or labeled by Insight Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Chamomilla (Chamomile) 3X, 6X, 12X, 30X	pain and sensitivity of teething, calming
Calcarea Phosphorica (Calcium Phosphate) 6X	pain and sensitivity of teething
Kali Phosphoricum (Potassium Phosphate) 6X	pain in mouth and gums
Magnesia Phosphorica (Magnesium Phosphate) 6X	pain and sensitivity of teething
Staphysagria (Delphinium Staphisagria) 9X	pain and sensitivity of teething

Uses

temporarily relieves sore gums and restlessness and irritability due to teething in infants and children 4 months and older

Warnings

Do not use more than directed.

When using this product

• fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms do not go away, advise your physician or dentist.

Stop use and ask a physician or dentist if

• sore mouth symptoms do not get better in 7 days
• irritation, pain, or redness persists or worsens
• swelling, rash or fever develops

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

• children and infants over 4 months of age, place one half dropper (0.5mL) under the tongue every 2 hours. Once symptoms improve reduce to 4 times daily.
• for infants under 4 months of age, ask a physician or dentist.

Other information

• Do not use if white neck band printed with "sealed for your protection" is broken or missing.
• Store tightly closed at room temperature 15°-25°C (59°-77°F).
• Keep carton for full drug facts.

Inactive ingredients

citric acid, glycerin, purified water, sodium benzoate

Questions?

call 1-800-344-7239 or visit our website at www.gentlenaturals.com

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Distributed by:

INSIGHT Pharmaceuticals Corp. Langhorne, PA 19047-1749

PRINCIPAL DISPLAY PANEL - 29.6 mL Bottle Carton

Gentle
Naturals®

Homeopathic
Teething Drops

Relieves Teething Pain
100% Natural with Chamomile
with No Known Side Effects

1 FL OZ (29.6 mL)

INGREDIENTS AND APPEARANCE

GENTLE NATURALS 
matricaria recutita, tribasic calcium phosphate, potassium phosphate, dibasic, magnesium phosphate, dibasic trihydrate, and delphinium staphisagria seed liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63736-318
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ)	Matricaria Recutita	30 [hp_X]  in 1 mL
Tribasic Calcium Phosphate (UNII: 91D9GV0Z28) (Calcium Cation - UNII:2M83C4R6ZB)	Tribasic Calcium Phosphate	6 [hp_X]  in 1 mL
Potassium Phosphate, Dibasic (UNII: CI71S98N1Z) (Potassium Cation - UNII:295O53K152)	Potassium Phosphate, Dibasic	6 [hp_X]  in 1 mL
Magnesium Phosphate, Dibasic Trihydrate (UNII: HF539G9L3Q) (Magnesium Cation - UNII:T6V3LHY838)	Magnesium Phosphate, Dibasic Trihydrate	6 [hp_X]  in 1 mL
Delphinium Staphisagria Seed (UNII: 00543AP1JV) (Delphinium Staphisagria Seed - UNII:00543AP1JV)	Delphinium Staphisagria Seed	9 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Sodium Benzoate (UNII: OJ245FE5EU)

Product Characteristics
Color	WHITE (Clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63736-318-24	24 in 1 CASE
1		1 in 1 BOX
1		30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		06/20/2010

Labeler - Insight Pharmaceuticals (176792315)