TEETHING KIDS RELIEF BABY- chamomilla, arnica montana, borax, hypericum perforatum liquid

Teething Kids Relief Baby by

Drug Labeling and Warnings

Teething Kids Relief Baby by is a Homeopathic medication manufactured, distributed, or labeled by HOMEOLAB USA INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

REFERENCES

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 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

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

INGREDIENTS AND APPEARANCE

TEETHING KIDS RELIEF BABY 
chamomilla, arnica montana, borax, hypericum perforatum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60512-9202
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	5 [hp_C]  in 25 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	5 [hp_C]  in 25 mL
SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22)	SODIUM BORATE	5 [hp_C]  in 25 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	5 [hp_C]  in 25 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Characteristics
Color		Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60512-9202-8	1 in 1 BOX	09/01/2016
1		25 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/01/2016

Labeler - HOMEOLAB USA INC (202032533)

Establishment
Name	Address	ID/FEI	Business Operations
HOMEOLAB USA INC		202032533	manufacture(60512-9202)