Label: HEMCALM- horse chestnut, hamamelis virginiana root bark/stem bark, paeonia officinalis root, krameria lappacea root suppository
- NDC Code(s): 0220-9179-67
- 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 February 14, 2024
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active Ingredients** (in each suppository)
Aesculus hippocastanum 7X HPUS (0.01 g)
Hamamelis virginiana 2X HPUS (0.01 g)
Paeonia officinalis 2X HPUS (0.01 g)
Ratanhia 7X HPUS (0.01 g)
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
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PURPOSE
Purpose*
Aesculus hippocastanum 7X HPUS (0.01g) ... Reduces swelling and relieves stinging pain associated with internal and external hemorrhoids
Hamamelis virginiana 2X HPUS (0.01g) ... Relieves burning, itching and discomfort associated with hemorrhoids
Paeonia officinalis 2X HPUS (0.01g) ... Relieves burning pain and oozing associated with internal and external hemorrhoids
Ratanhia 7X HPUS (0.01g) ... Relieves itching and discomfort from internal and external hemorrhoids, especially during and after bowel movements
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- Adults and children 12 years of age and older: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Insert 1 HemCalm suppository rectally morning and night.
- Children under 12 years of age: Ask a doctor.
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HEMCALM
horse chestnut, hamamelis virginiana root bark/stem bark, paeonia officinalis root, krameria lappacea root suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-9179 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PAEONIA OFFICINALIS ROOT (UNII: 8R564U2E1P) (PAEONIA OFFICINALIS ROOT - UNII:8R564U2E1P) PAEONIA OFFICINALIS ROOT 2 [hp_X] HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT 7 [hp_X] HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 2 [hp_X] KRAMERIA LAPPACEA ROOT (UNII: P29ZH1A35Z) (KRAMERIA LAPPACEA ROOT - UNII:P29ZH1A35Z) KRAMERIA LAPPACEA ROOT 7 [hp_X] Inactive Ingredients Ingredient Name Strength HARD FAT (UNII: 8334LX7S21) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0220-9179-67 10 in 1 BOX; Type 0: Not a Combination Product 01/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/2020 Labeler - Boiron (282560473) Registrant - Boiron, Inc. (014892269) Establishment Name Address ID/FEI Business Operations Boiron 282560473 manufacture(0220-9179)
