DOLODENT MAX STRENGTH- arnica montana, asafoedida, chamomilla, hecla lava, hypericum liquid

Dolodent by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredients & Purposes

• Active ingredients**(HPUS): Purposes*
• Arnica montana 30X: Pain in the tooth, with inflammation
• Asa foetida 6X: Cavity pain
• Chamomilla vulgaris 30: 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 well before use

adults 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 and allow in place for at least 1 minute and spit out
• repeat as needed

children under 12 years of age: consult a dentist or doctor

Inactive ingredients

clove oil, polysorbate 20, sucrose, water

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

Made in India

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-400
Route of Administration	BUCCAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
WATER (UNII: 059QF0KO0R)
CLOVE OIL (UNII: 578389D6D0)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-400-15	1 in 1 BOX	12/01/2023
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		12/01/2023

Labeler - Pharmadel LLC (030129680)