TEETHING- tribasic calcium phosphate, matricaria recutita, arabica coffee bean, and atropa belladonna gel
Hyland's

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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Teething

Drug Facts

Active ingredients	Purpose
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Calcarea Phosphorica 12X HPUS	teething, dentition
Chamomilla 6X HPUS	irritability
Coffea Cruda 6X HPUS	sleeplessness
Belladonna 6X HPUS (0.0000003% alkaloids, calculated)	redness and teething discomfort

Uses

Temporarily relieves symptoms of pain, simple restlessness and wakeful irritability due to cutting teeth. Helps reduce redness and teething discomfort.

Warnings

Do not use:

more often than directed
for more than 7 days in a row unless directed by doctor or dentist
if your child has a known allergy to any ingredient in this product

Stop use and ask a doctor if:

symptoms do not improve in 7 days
swelling, rash or fever develops
irritation, pain or redness persist or worsen

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

Directions

wash hands
cut 1/8" off tip of tube to open
children under 3 years of age: apply 1/4" ribbon to finger and rub carefully onto child's gums every 15 minutes as necessary
please note: if your child has been crying or upset, your child may fall asleep after using this product because the pain has been relieved and your child can rest.

Other information

do not use if tube tip is broken or missing.
Hyland's may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Inactive ingredients

Citric Acid, Hydroxyethylcellulose, Potassium Sorbate, Purified Water, Sodium Benzoate, Sorbic Acid, Vegetable Glycerine.

Questions or comments?

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 14.7 mL Tube Carton

Teething Gel

Natural
Relief

FAST RELIEF OF PAIN AND
IRRITABILITY FROM TEETHING

Principal Display Panel - 14.7 mL Tube Carton

TEETHING
tribasic calcium phosphate, matricaria recutita, arabica coffee bean, and atropa belladonna gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54973-7521
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	12 [hp_X] in 1 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	6 [hp_X] in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	6 [hp_X] in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	6 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBIC ACID (UNII: X045WJ989B)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54973-7521-2	1 in 1 CARTON	04/17/2009	01/03/2017
1		14.7 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		04/17/2009	01/03/2017

Labeler - Hyland's (028570695)

Name	Address	ID/FEI	Business Operations
Establishment
Standard Homeopathic Company		008316655	manufacture(54973-7521) , pack(54973-7521)

Name	Address	ID/FEI	Business Operations
Establishment
Nexgen Pharma, Inc.		079424083	manufacture(54973-7521) , pack(54973-7521)

Revised: 10/2017

Document Id: 5c51d2c8-89bf-a299-e053-2991aa0a1e2f

Set id: e5a07b4b-e53d-489f-b7f7-a4e45dbd2152

Version: 4

Effective Time: 20171024

Hyland's