FDA Label for Hemcalm
View Indications, Usage & Precautions
Hemcalm 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
AESCULUS HIPPOCASTANUM 1X HPUS 1.3%, COLLINSONIA CANADENSIS 1X HPUS 1.3%, HAMAMELIS VIRGINIANA 1X HPUS 1.3%
Otc - Purpose
AESCULUS HIPPOCASTANUM 1X HPUS 1.3% REDUCES SWELLING AND RELIEVES STINGING PAIN ASSOCIATED WITH EXTERNAL HEMORRHOIDS*
COLLINSONIA CANADENSIS 1X HPUS 1.3% RELIEVES HEMORROIDS ASSOCIATED WITH CONSTIPATION*
HAMAMELIS VIRGINIANA 1X HPUS 1.3% RELIEVES BURNING, ITCHING AND DISCOMFORT ASSOCIATED WITH HEMORRHOIDS*
Indications & Usage
TEMPORARILY RELIEVES SYMPTOMS OF HEMORRHOIDS SUCH AS: BURNING, ITCHING, SWELLING, PAIN, DISCOMFORT. HELPS SHRINK SWOLLEN HEMORRIODS. RELIEVES HEMORRHOID SYMPTOMS FOLLOWING CHILDBIRTH.
Warnings
FOR EXTERNAL USE ONLY.
DO NOT PUT THIS PRODUCT INTO THE RECTUM BY USING FINGERS OR ANY MECHANICAL DEVICE OR APPLICATOR.
WHEN USING THIS PRODUCT, DO NOT EXCEED THE RECOMMENDED DAILY DOSAGE UNLESS DIRECTED BY A DOCTOR.
Otc - Ask Doctor
ASK A DOCTOR BEFORE USE IN CASE OF BLEEDING.
Otc - Stop Use
STOP USE AND ASK A DOCTOR IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS OR WORSEN.
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. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
Dosage & Administration
ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER: WHEN PRACTICAL, GENTLY CLEANSE THE AFFECTED AREA WITH MILD SOAP AND WARM WATER AND RINSE THROUGHLY. GENTLY DRY BY PATTING OR BLOTTING WITH TOILET TISSUE OR A SOFT CLOTH BEFORE APPLICAITON OF PRODUCT. APPLY HEMCALM OINTMENT EXTERNALLY TO THE AFFECTED AREA UP TO 4 TIMES A DAY. CHILDREN UNDER 12 YEARS OF AGE: ASK A DOCTOR.
Other
DO NOT USE IF GLUED CARTON AND FLAPS ARE OPEN OR IF THE TUBE SEAL IS BROKEN.
TUBE 1 OZ. (30G)
STORE AT 68-77° F (20-25° C)
*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.
The letters "HPUS" indicate that the components in this product are offically monographed in the Homeopathic Pharmacopoeia of the United States.
Soothing Relief
Reduces Swelling
Plant Base Actives
Paraben Free
Inactive Ingredient
ALCOHOL, WHITE PETROLATUM USP
Otc - Questions
1-800-BOIRON-1 (1-800-264-7661),
BoironUSA.com [email protected]
Distributed by Boiron, Inc. Newtown Square, PA 19073
* Please review the disclaimer below.