INFANTS TEETHING LIQUID- chamomilla, arnica montana, borax, hypericum perforatum liquid 
CVS PHARMACY

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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DRUG FACTS

Active ingredients HPUS:

Chamomilla (German chamomile) 5C

Arnica montana (Leopard's bane) 5C

Borax (Sodium borate) 5C

Hypericum perforatum (St.John's wort) 5C

Purpose

Chamomilla (German chamomile) 5C .....................................................gum pain, restlessness, irritability and agitation

Arnica montana (Leopard's bane) 5C ......................................................toothache and fever

Borax (Sodium borate) 5C .....................................................................gum inflammation and diarrhea

Hypericum perforatum (St.John's wort) 5C ..............................................dental nerve pain

The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.

Uses

This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve indispositions caused by teething:

*Thses claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

Warnings

Do not use if seal under bottle cap is broken or missing.

Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist for more than 3 days.

Keep out of reach of children.

Directions

Age: Infants and children 0 to 9 years of age

Dose: 0.75 mL

Other information

Store at room temperature.

Inactive ingredients

Purified water, sorbitol, sodium benzoate, potassium sorbate, citric acid, orange oil.

RETAIN CARTON FOR COMPLETE INSTRUCTIONS

CARTON

image of carton

INFANTS TEETHING LIQUID 
chamomilla, arnica montana, borax, hypericum perforatum liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-642
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE5 [hp_C]  in 25 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA5 [hp_C]  in 25 mL
SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE5 [hp_C]  in 25 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM5 [hp_C]  in 25 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-642-021 in 1 CARTON
125 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/25/2014
Labeler - CVS PHARMACY (062312574)
Registrant - HOMEOLAB USA INC (202032533)
Establishment
NameAddressID/FEIBusiness Operations
HOMEOLAB USA INC202032533manufacture(59779-642)

Revised: 2/2014
Document Id: 929b711c-2a6d-4c1f-976d-a315a01e4266
Set id: 518069c3-6c91-43fa-9e7b-ba7d244cfb8b
Version: 1
Effective Time: 20140225
 
CVS PHARMACY