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#

ProductACNE RELIEF
Active ingredientPOTASSIUM BROMIDE, SYZYGIUM JAMBOS SEED, SELENIUM
Label structure11 sections

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

labellabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9101-43ACNE RELIEF80 in 1 TUBEPELLET802
0220-9101-43ACNE RELIEF3 in 1 BOXPELLET32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9101ACNE RELIEF (POTASSIUM BROMIDE, SYZYGIUM JAMBOS SEED, SELENIUM) PELLET [BOIRON]2Current NDC, Legacy NDC, 2 package rows20231005_df21b4e0-8c14-1c4d-e053-2995a90a74c7.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-91010220-9101-43

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
ACNE RELIEFPOTASSIUM BROMIDE, SYZYGIUM JAMBOS SEED, SELENIUMBoirondf21b4e0-8c14-1c4d-e053-2995a90a74c72023-10-04Exact identifier
ndc (package): 0220-9101-43
ndc (product): 0220-9101
ndc11 (package): 00220910143
spl id: 06ea67d8-b617-776b-e063-6294a90a3185
spl set id: df21b4e0-8c14-1c4d-e053-2995a90a74c7

Reported adverse events (FAERS/openFDA)#

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