Label: HEMORRHOIDAL CREAM- glycerin, phenylephrine hydrochloride, pramoxine hydrochloride, white petrolatum cream
- NDC Code(s): 70000-0425-1
- Packager: Cardinal Health, Inc.
- 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 September 1, 2020
If you are a consumer or patient please visit this version.
- Active ingredients
- for temporary relief of pain, soreness and burning
- helps relieve the local itching and discomfort associated with hemorrhoids
- temporarily provides a coating for relief of anorectal discomforts
- temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful
- temporarily shrinks hemorrhoidal tissue
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
- 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.
- when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
- apply externally to the affected area up to 4 times daily, especially at night or in the morning or after each bowel movement.
- apply externally or in the lower portion of the anal canal only.
- 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.
Children under 12 years of age: consult a doctor.
- Other Information
- Inactive ingredients
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
glycerin, phenylephrine hydrochloride, pramoxine hydrochloride, white petrolatum cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0425 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 0.28 g in 28 g GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 4.032 g in 28 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 0.07 g in 28 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 4.2 g in 28 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0425-1 1 in 1 BOX 04/03/2019 1 28 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 04/03/2019 Labeler - Cardinal Health, Inc. (097537435) Establishment Name Address ID/FEI Business Operations zhejiang jingwei pharmaceutical co., ltd 530876549 manufacture(70000-0425)