Other
Drug Facts
Natureplex
FDA Label NDC 67234-025
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 67234-025). 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
Otc - Purpose
| Active ingredients | Purposes |
|---|---|
| Glycerin 14.4% | Protectant |
| Petrolatum 15% | Protectant |
| Phenylephrine hydrochloride 0.25% | Vasoconstrictor |
| Pramoxine hydrochloride 1% | Local Anesthetic |
Uses
- temporarily relieves pain, soreness, and burning
- helps relieve local itching and discomfort associated with hemorrhoids
- temporarily shrinks hemorrhoidal tissue
- temporarily provides a coating for relief of anorectal discomforts
- temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
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
- an allergic reaction develops
- the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase
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 cream.
- when first opening tube, remove foil seal
- apply externally or in lower portion of anal canal only
- apply externally to affected area up to 4 times daily, especially at night, in the morning, or after each bowel movement
- for application in lower anal canal; remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into anus
- thoroughly cleanse dispensing cap after each use, and replace cover
- 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, BHA, cetyl alcohol, citric acid, disodium EDTA, glyceryl stearate, laureth-23, methylparaben, mineral oil, panthenol, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, sodium carboxymethyl cellulose, steareth-2, steareth-20, stearyl alcohol, tocopheryl (vitamin E) acetate, xanthan gum
Questions Or Comments?
866-323-0107 or www.natureplex.com
Principal Display Panel - 26 G Tube Box
NDC 67234-025-01
Includes
Dispensing
Cap
Natureplex™
Anesthetic
HEMORRHOIDAL
Cream
With Soothing Aloe
NET WT. 0.9 Oz.(26g)
Maximum Strength Pain Relief
Principal Display Panel (26 g Tube Box)
* Please review the disclaimer below.
