DOLODENT- arnica montana, asafoedida, chamomilla vulg, hecla lava, hypericum perf liquid

Dolodent by

Drug Labeling and Warnings

Dolodent by is a Homeopathic medication manufactured, distributed, or labeled by Pharmadel LLC, JMM Services. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

• Active ingredients HPUS: Purpose
• Arnica Montana 30x..........: Pain in the teeth, with swelling of the cheeks
• Asafoedida 6x.............................: Bone pain
• Chamomilla vulg. 30x...............: Toothache
• Hecla lava 30x................: T oothache sensitive to pressure, with swelling of jaws
• Hypericum perf. 30x.....................: Sharp shooting pain Neuralgia

Uses

Temporarily relieves toothaches

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

Warnings

Ask a doctor or dentist if

Pregnant or breastfeeding
Under 12 years of age
Symptoms persist more than 2 days or reoccur
You are allergic to any of the ingredients

Keep this and all medications out of the reach of children

Do not use

if tamper neck band is broken or missing.

Question or comments?

1-866-359-3478 (M-F) 9AM to 5PM Eastern Time

Directions

Shake well before use. Soak a small piece of cotton or gauze and apply to painful area. Repeat as needed.

Inactive ingredients

Glycerin USP, Ethanol USP 20%, Clove oil, Propolis, Polysorbate 20

Principal Display Panel

DoloDent

• Toothache/Dolor de muela
• Sore gums/Dolor de encias
• Braces irritation/ Irritacion de frenos

DoloDent

MAXIMUM STRENGTH

Instant Relief

• Toothache
• Sore gums
• Braces irritation

DoloDent

Extra Fuerte

Alivio Instantaneo

• Dolor de muela
• Dolor de encias
• Irritacion de frenos

GOTAS BUCALES

HOMEOPATICAS

Contenido Neto: 15mL

INGREDIENTS AND APPEARANCE

DOLODENT 
arnica montana, asafoedida, chamomilla vulg, hecla lava, hypericum perf liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-029
Route of Administration	BUCCAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	30 [hp_X]  in 1 mL
FERULA ASSA-FOETIDA RESIN (UNII: W9FZA51AS1) (FERULA ASSA-FOETIDA RESIN - UNII:W9FZA51AS1)	FERULA ASSA-FOETIDA RESIN	6 [hp_X]  in 1 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	30 [hp_X]  in 1 mL
HEKLA LAVA (UNII: C21158IIRK) (HEKLA LAVA - UNII:C21158IIRK)	HEKLA LAVA	30 [hp_X]  in 1 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	30 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CLOVE OIL (UNII: 578389D6D0)
GLYCERIN (UNII: PDC6A3C0OX)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-029-04	1 in 1 BOX	11/01/2017
1		15 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		11/01/2017

Labeler - Pharmadel LLC (030129680)

Registrant - JMM Services (003488666)