Label: NATUREPLEX HEMORRHOIDAL- glycerin, phenylephrine hydrochloride, pramoxine hydrochloride, and petrolatum cream
- NDC Code(s): 67234-025-01
- Packager: Natureplex LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 31, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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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
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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
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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
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- PRINCIPAL DISPLAY PANEL - 26 g Tube Box
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INGREDIENTS AND APPEARANCE
NATUREPLEX HEMORRHOIDAL
glycerin, phenylephrine hydrochloride, pramoxine hydrochloride, and petrolatum creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67234-025 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 0.144 mg in 1 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 0.0025 mg in 1 g PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 0.1 mg in 1 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 0.15 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) LAURETH-23 (UNII: N72LMW566G) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) PANTHENOL (UNII: WV9CM0O67Z) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM BENZOATE (UNII: OJ245FE5EU) STEARETH-2 (UNII: V56DFE46J5) STEARETH-20 (UNII: L0Q8IK9E08) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) TOCOPHEROL (UNII: R0ZB2556P8) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67234-025-01 1 in 1 BOX 03/01/2014 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 drug M015 03/01/2014 Labeler - Natureplex LLC (062808196) Establishment Name Address ID/FEI Business Operations Natureplex LLC 062808196 MANUFACTURE(67234-025)
