HEMORRHOIDAL CREAM- glycerin, phenylephrine hydrochloride, pramoxine hydrochloride, white petrolatum cream 
Cardinal Health, Inc.

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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Hemorrhoidal Cream

Active ingredients

Glycerin 14.4%

Phenylephrine HCl 0.25%

Pramoxine HCl 1%

White petrolatum 15%

Purpose

Protectant

Vasoconstrictor

Local anesthetic

Protectant

Uses

Warnings

For external use only.

When using this product

  • do not put this product into the rectum by using fingers or any mechanical device or applicator
  • do not exceed recommended daily dosage unless directed by a doctor

Ask a doctor before use if you have

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

Stop use and ask a doctor if

  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • the symptoms being treated do not subside or if redness, irritation, swelling, pain or other symptoms develop or increase. Some people can develop allergic reactions to ingredients in this product.

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 (1-800-222-1222) right away.

Directions

Adults:

Children under 12 years of age: consult a doctor.

Other Information

store at room temperature 68° - 77° F (20° - 25° C).

Inactive ingredients

aloe barbadensis leaf extract, carboxymethylcellulose sodium, cetyl alcohol, glyceryl monostearate, methylparaben, paraffin, propylene glycol, propylparaben, stearic acid, tween 80, water, xanthan gum

Questions?

1-800-639-3803 Weekdays 9 AM to 4 PM EST

Hemorrhoidal Cream Package

HEMORRHOIDAL CREAM 
glycerin, phenylephrine hydrochloride, pramoxine hydrochloride, white petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0425
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE0.28 g  in 28 g
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN4.032 g  in 28 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.07 g  in 28 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM4.2 g  in 28 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
XANTHAN GUM (UNII: TTV12P4NEE)  
WATER (UNII: 059QF0KO0R)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PARAFFIN (UNII: I9O0E3H2ZE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0425-11 in 1 BOX04/03/2019
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34604/03/2019
Labeler - Cardinal Health, Inc. (097537435)
Establishment
NameAddressID/FEIBusiness Operations
zhejiang jingwei pharmaceutical co., ltd530876549manufacture(70000-0425)

Revised: 9/2020
Document Id: ae480739-63df-5802-e053-2995a90a16d5
Set id: 85a51d5c-679e-1959-e053-2a91aa0a76d5
Version: 2
Effective Time: 20200901
 
Cardinal Health, Inc.