Label: NATUREPLEX HEMORRHOIDAL- witch hazel and phenylephrine hydrochloride gel
- NDC Code(s): 67234-024-01
- Packager: Natureplex LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated December 5, 2017
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- 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
For external use only.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- 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.
- 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
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 25.5 g Tube Box
INGREDIENTS AND APPEARANCE
witch hazel and phenylephrine hydrochloride gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67234-024 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL 0.5 mg in 1 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 0.0025 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:67234-024-01 1 in 1 BOX 03/18/2014 1 25 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part346 03/18/2014 Labeler - Natureplex LLC (062808196) Establishment Name Address ID/FEI Business Operations Natureplex LLC 062808196 MANUFACTURE(67234-024)