NATUREPLEX  HEMORRHOIDAL- witch hazel and phenylephrine hydrochloride gel 
Natureplex LLC

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.

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Natureplex™
Hemorrhoidal Cooling Gel

Drug Facts

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

Uses

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:

Other information

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
NATUREPLEX   HEMORRHOIDAL
witch hazel and phenylephrine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-024
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL0.5 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.0025 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZOPHENONE (UNII: 701M4TTV9O)  
HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%) (UNII: 12VCE9HR9E)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67234-024-011 in 1 BOX03/18/2014
125 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34603/18/2014
Labeler - Natureplex LLC (062808196)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(67234-024)

Revised: 12/2017
Document Id: c69046f5-7564-4cb2-a366-c04cc67a9a13
Set id: 0614c8ed-db34-4f32-bffa-891c3183ed1b
Version: 2
Effective Time: 20171205
 
Natureplex LLC