Label: FISSURE CONTROL- aloe, calendula officinalis flowering top, hamamelis virginiana root bark/stem bark, and lycopodium clavatum spore solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 51393-6333-1, 51393-6333-2 - Packager: Forces of Nature
- 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 August 24, 2010
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- Indications
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ACTIVE INGREDIENT
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- The letters 'HPUS' indicate that the components in this product are officially monographed in the Homœopathic Pharmacopœia of the United States.
Homeopathic Active Ingredients* Equal parts of: Purpose Aloe 6X HPUS Relief for hemorrhoids that are tender, sore, burning Calendula Officinalis 6X HPUS Promotes healthy skin and healing Mamamelis Virginiana 6X HPUS Relief of hemorrhoids that are sore or burning Lycopodium Clavatum Spore 6X HPUS Relief for painful hemorrhoids - Also Includes
- Directions
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Warnings
Some individuals may be sensitive to essential oils.Begin with a small drop to determine if the product causes any increased redness or irritation and discontinue use if it irritates your skin.
For external use only. If accidental ingestion, get medical help or contact a Poison Control Center. Do not apply to the eyes; in the event of contact, flush with water and seek advice from medical personnel.
Not to be used with children under 2 years of age. Keep all medicines out of the reach of children.
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- PRINCIPAL DISPLAY PANEL - 11 ml Bottle Label
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INGREDIENTS AND APPEARANCE
FISSURE CONTROL
aloe, calendula officinalis flowering top, hamamelis virginiana root bark/stem bark, and lycopodium clavatum spore solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51393-6333 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aloe (UNII: V5VD430YW9) (Aloe - UNII:V5VD430YW9) Aloe 6 [hp_X] in 1000 mL CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 6 [hp_X] in 1000 mL Hamamelis virginiana Root Bark/Stem Bark (UNII: T7S323PKJS) (Hamamelis virginiana Root Bark/Stem Bark - UNII:T7S323PKJS) Hamamelis virginiana Root Bark/Stem Bark 6 [hp_X] in 1000 mL Lycopodium clavatum Spore (UNII: C88X29Y479) (Lycopodium clavatum Spore - UNII:C88X29Y479) Lycopodium clavatum Spore 6 [hp_X] in 1000 mL Product Characteristics Color BLUE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51393-6333-1 11 mL in 1 BOTTLE, DISPENSING 2 NDC:51393-6333-2 33 mL in 1 BOTTLE, DISPENSING Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 09/01/2010 Labeler - Forces of Nature (050169130)