FDA.reportPublic FDA data

Rapidol Arnica Gel (Hwell)(DA)

Manufacturer
Pharmadel LLC
Effective date
2025-11-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-06-03 17:37:51

Label at a glance#

ProductRapidol Arnica
Active ingredientARNICA MONTANA WHOLE
Label structure10 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backaches arthritis strains bruises sprains

Dosage and administration

adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily. children under 2 years of age: do not use, consult a doctor

Storage and handling

store in a cool dry place do not use if foil seal under cap is torn, broken, or missing

Label contents#

Full prescribing information#

Active ingredient & Purposes

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredient **Purposes*
Arnica montana 1 X HPUS ........................................................Muscle aches and pains, bruises, swelling from injuries

The letters “HPUS” indicate that the components in this product are officially included in the Homeopathic Pharmacopoeia of the United States.

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backaches
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY. Avoid contact with the eyes.

Do not use

OTC - DO NOT USE SECTION

  • on wounds or damaged skin
  • on a bandage tightly

Stop use and consult a doctor

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

if pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

consult a doctor before using this product.

KEEP OUT OF THE REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily.
  • children under 2 years of age: do not use, consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • store in a cool dry place
  • do not use if foil seal under cap is torn, broken, or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera leaf, capryloyl glycine, hexylene glycol, hydroxyethyl cellulose, phenoxyethanol, potassium sorbate, methyl salicylate, water.

Questions or comments?

OTC - QUESTIONS SECTION

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

Distributed by:

SPL UNCLASSIFIED SECTION

PHARMADEL LLC.
New Castle, DE, 19720

Homeopathic Statements

SPL UNCLASSIFIED SECTION

*These “USES” claims have not been evaluated by the Food and Drug Administration (FDA). They are based upon traditional homeopathic practices.
**C, K, CK, and X are homeopathic dilutions.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP Arnica GelPDP Arnica Gel

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-40355758-403-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPRYLOYL GLYCINE8TY5YO42NJIACT
ALOE VERA LEAFZY81Z83H0XIACT
METHYL SALICYLATELAV5U5022YIACT
ARNICA MONTANA WHOLEO80TY208ZWACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
HEXYLENE GLYCOLKEH0A3F75JIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
437f9856-dff7-7f52-e063-6394a90af52b0517e283-81d9-5b52-e063-6294a90a4eaf2025-11-13WarningsExact identifier
spl id: 437f9856-dff7-7f52-e063-6394a90af52b
spl set id: 0517e283-81d9-5b52-e063-6294a90a4eaf

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.