ACNE RELIEF
- Manufacturer
- Boiron | Boiron, Inc. | Reed Lane, Inc.
- Effective date
- 2023-10-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 02:22:28
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients** (in each pellet)
Eugenia jambosa 6C HPUS (0.44 mg)
Kali bromatum 30C HPUS (0.44 mg) (contains less than 10 -12 mg bromine)
Selenium metallicum 6C HPUS (0.44 mg) (contains less than 10 -12 mg selenium)
The letters "HPUS" indicate that components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
OTC - PURPOSE SECTION
Purpose*
Eugenia jambosa 6C HPUS (0.44 mg) ... Treats blackheads associated with menstruation
Kali bromatum 30C HPUS (0.44 mg) ... Treats whitehead acne and scarring; sleeplessness with agitation
Selenium metallicum 6C HPUS (0.44 mg) ... Treats juvenile acne with blackheads and oily skin
INDICATIONS & USAGE SECTION
Uses*
temporarily relieves and treats occasional symptoms of acne (pimples) such as:
- blackheads
- oily skin
- whiteheads
- risk of scarring
- breakouts associated with puberty and menstrual periods
OTC - STOP USE SECTION
Stop and ask a doctor if
- symptoms persist for more than 3 days or worsen
- skin irritation occurs, gets worse, or is severe.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breastfeeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
Keep packaging to save these directions for use.
Adults and children:
Acne with Blackheads and Oily Skin: At the onset of symptoms, dissolve 5 pellets each of Selenium 6C and Eugenia jambosa 6C under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.
Acne with Whiteheads and Blackheads: At the onset of symptoms, dissolve 5 pellets each of Kali bromatum 30c and Selenium 6C under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.
INACTIVE INGREDIENT SECTION
lactose, sucrose
SPL UNCLASSIFIED SECTION
- do not use if glued carton end flaps are open or if pellet dispenser seal is broken
- contains 0.25 g of sugar per dose
ACNE RELIEF KIT*
Blackheads Oily Skin Whiteheads*
Treats Acne on Face & Body*
Works From the Inside Out
3 TUBES
APPROX. 80 PELLETS EACH
TOTAL 240 PELLETS
Turn tube upside down Twist until 5 pellets are dispensed Remove cap and 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.
OTC - QUESTIONS SECTION
BoironUSA.com
Info@Boiron.com
1-800-BOIRON-1 (1-800-264-7661)
Made in France
Distributed by Boiron, Inc.
Newtown Square, PA 19073
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 86fffa7b-d382-4771-a253-25cccb64b590 | Product name | 3 | 20251124 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0220-9101-43 | ACNE RELIEF | 80 in 1 TUBE | PELLET | 80 | 2 | |
| 0220-9101-43 | ACNE RELIEF | 3 in 1 BOX | PELLET | 3 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- ACNE RELIEF
- POTASSIUM BROMIDE, SYZYGIUM JAMBOS SEED, SELENIUM
- POTASSIUM BROMIDE
- BROMIDE ION
- SUCROSE
- LACTOSE, UNSPECIFIED FORM
- SYZYGIUM JAMBOS SEED
- SELENIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0220-9101 | 0220-9101-43 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POTASSIUM BROMIDE | OSD78555ZM | ACTIB |
| SUCROSE | C151H8M554 | IACT |
| LACTOSE, UNSPECIFIED FORM | J2B2A4N98G | IACT |
| SYZYGIUM JAMBOS SEED | 97P0H45869 | ACTIB |
| SELENIUM | H6241UJ22B | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ACNE RELIEF | POTASSIUM BROMIDE, SYZYGIUM JAMBOS SEED, SELENIUM | Boiron | df21b4e0-8c14-1c4d-e053-2995a90a74c7 | 2023-10-04 | 0220-9101-43 0220-9101 00220910143 06ea67d8-b617-776b-e063-6294a90a3185 df21b4e0-8c14-1c4d-e053-2995a90a74c7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
