Hemorrhoidal cream

Active ingredients

Glycerin 14.4%

Phenylephrine HCl 0.25%

Pramoxine HCl 1%

White petrolatum 15%

Purpose

Protectant

Vasoconstrictor

Local anesthetic

Uses

  • for temporary relief of pain, soreness and burning
  • helps relieve the 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

Warnings

For external use only

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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

  • 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
  • condition worsens or does not improve within 7 days
  • an allergic reaction develops
  • the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase

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.

Directions

  • 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.
  • when first opening the tube, puncture foil seal with top end of cap
  • apply externally or in the lower portion of the anal canal only
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • 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.
  • thoroughly cleanse dispensing cap after each use and replace cover
  • children under 12 years of age: ask a doctor

Other information

  • store at 20-25C (68-77F)

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?

1-800-719-9260

Ingredients and appearance - Product information

Hemorrhoidal cream- Glycerin, phenylephrine hcl, pramoxine hcl, white petrolatum

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 37808-944
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Glycerin ( UNII: PDC6A3C0OX)( Glycerin - UNII: PDC6A3C0OX ) 14.4 gin 100 g
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 0.25 gin 100 g
Pramoxine hydrochloride ( UNII: 88AYB867L5)( Pramoxine - UNII: 068X84E056 ) 1 gin 100 g
Petrolatum ( UNII: 4T6H12BN9U)( Petrolatum - UNII: 4T6H12BN9U ) 15 gin 100 g

Inactive Ingredients

Ingredient Name Code
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

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part346 USA

Labeler - H E B( 007924756)

Principal display panel

Compare to the active ingredients of Preparation H ®Cream

H E M O R R H O I D A L C R E A M

Maximum Strength Pain Relief

Smooth Cream Formula with Aloe

Rapid Soothing Pain Relief From Painful Burning, Itching And Discomfort

Shrinks Swollen Hemorrhoidal Tissue

Protects Irritated Tissue

Relieves External Discomfort