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

----------

Dolodent (HWell)

Drug Facts

Active ingredients & Purposes

Active ingredients**(HPUS) Purposes*
Arnica montana 30XPain in the tooth, with inflammation
Asa foetida 6XCavity pain
Chamomilla vulgaris 30Irritation, toothache, sore gums
Hekla lava 30XTooth sensitive to pressure, with swollen gums
Hypericum perforatum 30XSharp 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

adults and children 12 years of age and over:

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

DD PDP HW

DOLODENT  MAX STRENGTH
arnica montana, asafoedida, chamomilla, hecla lava, hypericum liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-400
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_X]  in 1 mL
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE30 [hp_X]  in 1 mL
FERULA ASSA-FOETIDA RESIN (UNII: W9FZA51AS1) (FERULA ASSA-FOETIDA RESIN - UNII:W9FZA51AS1) FERULA ASSA-FOETIDA RESIN6 [hp_X]  in 1 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM30 [hp_X]  in 1 mL
HEKLA LAVA (UNII: C21158IIRK) (HEKLA LAVA - UNII:C21158IIRK) HEKLA LAVA30 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
WATER (UNII: 059QF0KO0R)  
CLOVE OIL (UNII: 578389D6D0)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-400-151 in 1 BOX12/01/2023
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/01/2023
Labeler - Pharmadel LLC (030129680)

Revised: 11/2023
Document Id: 09c282c0-4e67-8772-e063-6294a90ae4dd
Set id: 042748e2-e755-570e-e063-6394a90a150a
Version: 3
Effective Time: 20231107
 
Pharmadel LLC