Drug Facts

Active ingredients & Purposes

Active ingredients** (HPUS)	Purposes*
Arnica montana 30X	Pain in the tooth, with inflammation
Asafoetida 6X	Cavity pain
Chamomilla vulgaris 30X	Irritation, toothache, sore gums
Hekla lava 30X	Tooth sensitive to pressure, with swollen gums
Hypericum perforatum 30X	Sharp shooting pain, due to toothache

**The letters HPUS indicate that this ingredient is officially included in the Homeopathic Pharmacopeia of the United States.

Uses*

For the temporary relief of oral pain due to minor irritation of the mouth and gums.

Warnings

Do not use

this product for more than 7 days
if you are allergic to any ingredients in this product

Stop use and ask your doctor or dentist if

sore mouth symptoms do not improve in 7 days
irritation, pain, or redness persists or worsens
swelling, rash, or fever develops

If pregnant or breastfeeding,

seek professional advice before taking this product.

Keep out of the reach of children.

In case of an accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

shake bottle well use
adult and children 12 years of age and over:
add 2-3 drops to a small piece of cotton or gauze
apply to the affected area for about 1 minute
repeat as needed
children under 12 years of age: consult the advice and supervision of a dentist or doctor

Inactive ingredients

alcohol, clove oil, glycerin, polysorbate 20, propolis

Question & comments?

+1-866-359-3478 (M-F) 9AM to 5PM EST or www.pharmadel.com

Distributed by:/ Distribuido por:

PHARMADEL
New Castle, DE, 19720
+ 1-866-359-3478
www.pharmadel.com
FB/ PHARMADELUSA

Homeopathic Statements

*These “USES” claims have not been evaluated by the Food and Drug Administration (FDA). They are based on traditional homeopathic practices.

**C, K, CK and X are homeopathic dilutions.

Principal Display Panel

DD_PDP_HC

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55758-324
Route of Administration	BUCCAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	30 [hp_X] in 1 mL
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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55758-324-15	1 in 1 BOX	09/09/2023
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		11/01/2017

Labeler - Pharmadel LLC (030129680)

Dolodent (HCare)