Label: EQUALINE HEMORRHOIDAL- glycerin, phenylephrine hcl, pramoxine hcl, white petrolatum cream
- NDC Code(s): 41163-944-24
- Packager: United Natural Foods, Inc. dba UNFI
- 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.
Drug Label Information
Updated August 9, 2023
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
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Uses
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- for temporary relief of pain, soreness and burning
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- helps relieve the local itching and discomfort associated with hemorrhoids
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- temporarily shrinks hemorrhoidal tissue
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- temporarily provides a coating for relief of anorectal discomforts
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- 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
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
presently taking a prescription drug for high blood pressure or depression
When using this product
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- do not exceed the recommended daily dosage unless directed by a doctor
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- do not put into the rectum by using fingers or any mechanical device or applicator
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Directions
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- adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying cream.
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- when first opening the tube, puncture foil seal with top end of cap
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- apply externally or in the lower portion of the anal canal only
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- apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
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- for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus.
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- thoroughly cleanse dispensing cap after each use and replace cover
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- children under 12 years of age: ask a doctor
- Other information
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Inactive ingredients
aloe barbadensis leaf extract, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid, edetate disodium, glyceryl monostearate, laureth-23, methylparaben, mineral oil, panthenol, propyl gallate, propylparaben, purified water, sodium benzoate, steareth-2, steareth-20, stearyl alcohol, vitamin E, xanthan gum
- Questions or comments?
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Principal Display Panel
EQUALINE®
compare to Preparation H® Cream active ingredients
hemorrhoidal cream
• rapid soothing pain relief from painful burning, itching and discomfort
• shrinks swollen hemorrhoidal tissue • protects irritated tissue
• relieves external discomfort
maximum strength pain relief • smooth cream formula with aloe
NET WT 1.8 OZ (51g)
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INGREDIENTS AND APPEARANCE
EQUALINE HEMORRHOIDAL
glycerin, phenylephrine hcl, pramoxine hcl, white petrolatum creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-944 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 14.4 g in 100 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 0.25 g in 100 g PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 1 g in 100 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 15 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) CETYL ALCOHOL (UNII: 936JST6JCN) 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) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) STEARETH-2 (UNII: V56DFE46J5) STEARETH-20 (UNII: L0Q8IK9E08) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41163-944-24 1 in 1 CARTON 03/28/2008 1 51 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 03/28/2008 Labeler - United Natural Foods, Inc. dba UNFI (943556183)
