TEETHING KIDS RELIEF- chamomilla, arnica montana, borax, hypericum perforatum liquid 
HOMEOLAB USA INC

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

Gum pain, restlessness, irritability and agitation

Toothache and fever

Gum inflammation and diarrhea

Dental nerve pain

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

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

RETAIN CARTON FOR COMPLETE INSTRUCTIONS

Uses

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

• gum inflammation

• gum pain

• fever

• diarrhea

• restlessness and irritability

Warnings



Do not use if imprinted shrink seal neckband 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

Children under 6 months of age: Consult a licensed healthcare practitioner before using this product.

Children 6 months to 2 years old: 0.5 ml orally every 8 hours or 3 times a day.

Children 2 to 9 years old: 0.75 ml orally every 8 hours or 3 times a day.

Other Information

Store at room temperature.

Inactive Ingredients

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

CARTON

image of carton label

LABEL

image of bottle label

TEETHING KIDS RELIEF 
chamomilla, arnica montana, borax, hypericum perforatum liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-9060
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA5 [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:60512-9060-81 in 1 CARTON
125 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/18/2008
Labeler - HOMEOLAB USA INC (202032533)
Establishment
NameAddressID/FEIBusiness Operations
HOMEOLAB USA INC202032533manufacture(60512-9060)

Revised: 4/2014
Document Id: 7fc50292-4009-4941-b5e0-29e05f03f92c
Set id: 8d87055c-44b4-4fce-8616-c4fac11cf294
Version: 2
Effective Time: 20140403
 
HOMEOLAB USA INC