Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Fumaria officinalis 6X (**contains 0.443 mg of the active ingredient per pellet)
Fumaria officinalis
- Manufacturer
- Boiron | Boiron Inc.
- Effective date
- 2023-07-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 02:21:54
Key Label Information#
Uses
INDICATIONS & USAGE SECTION
Dry skin rash with itching*
Warnings
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding ask a health professional before use
Directions And Dosage
DOSAGE & ADMINISTRATION SECTION
Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.
Other Label Information
INACTIVE INGREDIENT SECTION
lactose, sucrose
OTC - QUESTIONS SECTION
1-800-BOIRON-1 (1-800-264-7661), BoironUSA.com Info@boiron.com Distributed by Boiron, Inc. Newtown Square, PA 19073
Label Images#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0220-2176-41 | 2023-07-31 | C162847 | 48780-1 | f386c649-fd90-0266-e053-dadaa90a7c1a | Fumaria officinalis 6X |
| 0220-2176-41 | 2023-01-30 | C162847 | 48780-1 | f386c649-fd90-0266-e053-dadaa90a7c1a | Fumaria officinalis 6X |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0220-2176-41 | Fumaria officinalis | 6 [hp_X] in 1 TUBE | PELLET | 6 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
- Fumaria officinalis
- ANHYDROUS LACTOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0220-2176 | 0220-2176-41 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| FUMARIA OFFICINALIS FLOWERING TOP | VH659J61ZL | ACTIB |
| SUCROSE | C151H8M554 | IACT |
| LACTOSE, UNSPECIFIED FORM | J2B2A4N98G | IACT |
Complete SPL Sections#
OTC - ACTIVE INGREDIENT SECTION
Fumaria officinalis 6X (**contains 0.443 mg of the active ingredient per pellet)
INDICATIONS & USAGE SECTION
Dry skin rash with itching*
OTC - STOP USE SECTION
Stop use and ask a doctor if symptoms persist for more than 3 days or worsen
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding ask a health professional before use
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
SPL UNCLASSIFIED SECTION
Do not use if pellet dispenser seal is broken. Contains approx 80 pellets. How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue. *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED. *C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.
INACTIVE INGREDIENT SECTION
lactose, sucrose
DOSAGE & ADMINISTRATION SECTION
Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.
OTC - QUESTIONS SECTION
1-800-BOIRON-1 (1-800-264-7661), BoironUSA.com Info@boiron.com Distributed by Boiron, Inc. Newtown Square, PA 19073