The following Structured Product Label (SPL) was submitted to the FDA by Boiron for the product Acne Relief (NDC 0220-9101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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*
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
Uses*
temporarily relieves and treats occasional symptoms of acne (pimples) such as:
Stop and ask a doctor if
If pregnant or breastfeeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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.
lactose, sucrose
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.
BoironUSA.com
1-800-BOIRON-1 (1-800-264-7661)
Made in France
Distributed by Boiron, Inc.
Newtown Square, PA 19073
* Please review the disclaimer below.
