The following Structured Product Label (SPL) was submitted to the FDA by Apotheca Company for the product Hemorrhoid Care (NDC 57520-0778). 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, warnings, dosage & administration, inactive ingredient, otc - keep out of reach of children, indications & usage, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
ACTIVE INGREDIENTS: Hamamelis virginiana 1X, Aesculus hippocastanum 1X, 30C, Aloe socotrina 6X, Paeonia officinalis 6X, Ignatia amara 12X, Lycopodium clavatum 12X, Nitricum acidum 12X, Nux vomica 12X, Phosphorus 12X, Podophyllum peltatum 12X, Pulsatilla 12X, Sulphur 12X, Ratanhia 12X, 30X, Chelidonium majus 30C.
INDICATIONS: For temporary relief of itching and discomfort associated with hemorrhoids.
WARNINGS: If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Do not use if tamper evident seal is broken or missing.
Store in a cool, dry place
For topical use only.
DIRECTIONS: Apply a small amount externally to the affected area up to 6 times daily or after each bowel movement. Children under 12 years of age: Consult a doctor.
INACTIVE INGREDIENTS: Citric acid, Ethanol, Glycerin, Hydroxyethylcellulose, Purified water, Sodium benzoate.
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.
INDICATIONS: For temporary relief of itching and discomfort associated with hemorrhoids.
Dist. By:
MedCare Group
Boothwyn, PA 19060
302-260-3111
www.medcaregroups.com
MEDCARE
Hemorrhoid Care
HOMEOPATHIC GEL
Net. Wt. 2 OZ
Hemorrhoid Care (Mm1)
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