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Natureplex Hemorrhoidal by Natureplex LLC

Medically reviewed on December 5, 2017

Dosage form: gel
Ingredients: WITCH HAZEL 0.5mg in 1g, PHENYLEPHRINE HYDROCHLORIDE 0.0025mg in 1g
Labeler: Natureplex LLC
NDC Code: 67234-024

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Natureplex™
Hemorrhoidal Cooling Gel

Drug Facts

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

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.

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: 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

NATUREPLEX   HEMORRHOIDAL
witch hazel and phenylephrine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-024
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WITCH HAZEL (WITCH HAZEL) WITCH HAZEL0.5 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE0.0025 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS TRISODIUM CITRATE 
ALOE VERA LEAF 
BENZOPHENONE 
HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%) 
EDETATE DISODIUM 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
Packaging
#Item CodePackage Description
1NDC:67234-024-011 TUBE in 1 BOX
125 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34603/18/2014
Labeler - Natureplex LLC (062808196)
Establishment
NameAddressID/FEIOperations
Natureplex LLC062808196MANUFACTURE(67234-024)

 
Natureplex LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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