Natureplex
FDA Label NDC 67234-024

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natureplex Llc for the product Natureplex (NDC 67234-024). 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 other, otc - purpose, uses, warnings, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredientsPurposes
Phenylephrine HCl 0.25%Hemorrhoidal (anorectal) Gel
Hamamelis Virginiana (witch hazel) 50%Hemorrhoidal (anorectal) Gel

Uses

  • temporarily relieves anorectal itching and discomfort associated with hemorrhoids or anorectal disorders
  • temporarily reduces the swelling associated with irriation in hemorrhoids and other anorectal disorders
  • temporarily shrinks hemorrhoidal tissue
  • aids in protecting irritated anorectal areas
  • temporary relief of burning

Warnings

For external use only.

Ask A Doctor Before Use If You Have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty urinating due to enlargement of the prostate gland

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking a prescription drug for high blood pressure or depression

When Using This Product

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Doctor If

  • bleeding occurs
  • the condition worsens or does not improve within 7 days. These may be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, 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: 800-222-1222.

Directions

Adults:

  • when practical, cleanse affected area by patting or blotting with appropriate cleansing wipe. Gently dry by patting or blotting with tissue or soft cloth before applying gel.
  • apply externally to affected area up to 4 times daily or after each bowel movement
  • Children under 12 years: ask a doctor

Other Information

  • store at 15 to 30°C (59 to 86°F)
  • close cap tightly after use
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive Ingredients

aloe barbadensis leaf juice, benzophenone-4, disodium EDTA, hydroxyethylcellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

Questions Or Comments?

866-323-0107 or www.natureplex.com

Principal Display Panel - 25.5 G Tube Box

NDC 67234-024-01

Natureplex™

Anesthetic
HEMORRHOIDAL
Cooling Gel With Soothing Aloe

NET WT. 0.9 Oz.(25.5g)

Fast Cooling Relief

Principal Display Panel (25.5 g Tube Box)

Principal Display Panel (25.5 g Tube Box)

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