Dolodent by Pharmadel LLC Dolodent (HCare)

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]

DOLODENT- arnica montana, chamomilla, hecla lava, hypericum, asafoedida liquid 
Pharmadel LLC

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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Dolodent (HCare)

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

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

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
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: 55758-324-15	1 in 1 BOX	09/09/2023	06/02/2025
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	06/02/2025

Labeler - Pharmadel LLC (030129680)

Revised: 9/2023

Document Id: 0647abcf-743b-cbed-e063-6294a90ad272

34390-5

Set id: ac3af7cf-e379-32c9-e053-2a95a90abae8

Version: 10

Effective Time: 20230926