FDA Label for Acne Relief
View Indications, Usage & Precautions
Acne Relief Product Label
The following document was submitted to the FDA by the labeler of this product Boiron. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - 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.
Otc - Purpose
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
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
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
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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
lactose, sucrose
Other
- 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
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.