Label: ACNE RELIEF- potassium bromide, syzygium jambos seed, selenium pellet
- NDC Code(s): 0220-9101-43
- Packager: Boiron
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated October 4, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
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.
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
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
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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. - QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACNE RELIEF
potassium bromide, syzygium jambos seed, selenium pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-9101 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE 30 [hp_C] SYZYGIUM JAMBOS SEED (UNII: 97P0H45869) (SYZYGIUM JAMBOS SEED - UNII:97P0H45869) SYZYGIUM JAMBOS SEED 6 [hp_C] SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM 6 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) Product Characteristics Color white Score Shape ROUND Size 4mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0220-9101-43 3 in 1 BOX 05/16/2022 1 80 in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/16/2022 Labeler - Boiron (282560473) Registrant - Boiron, Inc. (014892269) Establishment Name Address ID/FEI Business Operations Reed Lane, Inc. 001819879 pack(0220-9101) Establishment Name Address ID/FEI Business Operations Boiron 282560473 manufacture(0220-9101)
