Statement Of Identity
Hemorrhoidal Cream
Hemporrhoid
FDA Label NDC 76348-590
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Renu Laboratories, Inc. for the product Hemporrhoid (NDC 76348-590). 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 statement of identity, otc - active ingredient, otc - purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Lidocaine HCl 5%
Otc - Purpose
Topical Anesthetic
Uses
For the temporary relief of
- Pain
- Itching
- Burning associated with inflamed hemorrhoidal tissues
Warnings
For external use only
Otc - When Using
When using this product
- Keep out of eyes. Rinse with water to remove. Do not use in large quantities, particularly over raw surfaces or blistered areas.
Otc - Stop Use
Stop use and ask a doctor if conditions worsen, or, if symptoms persist for more than 7 days, or clear up and occur again within a few days. Discontinue use of this product and consult a doctor.
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Directions:
Adults and children 2 years of age and older: apply to affected area not more than 3 - 4 times daily.
Children under 2 years of age: Consult a doctor.
Other Safety Information
Other information: Store between 58 - 87° F
Protect from freezing, direct heat or sunlight.
Otc - Questions
Questions? www.marswellness.com
Mars Wellness
Lakewood, NJ 08701
Inactive Ingredient
INGREDIENTS: Capryl Glycol, Caprylic / Capric Triglyceride, Cetearyl Alcohol, Deionized Water, Emulsifying Wax NF, Ethylhexylglycerin, Glycerin, Hemp Extract with proprietary Terpene blend: (Beta Caryophyllene, Humulene, Limonene, Myrcene, Linalool, Nerolidol, Beta Pinene, Alpha Pinene, Eucalyptol), Hexylene Glycol, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Stearic Acid, Tetrasodium EDTA, Tocopherol.
Package Label.Principal Display Panel
HEMPORRHOID TUBE ART
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