Label: HEMORRHOIDAL CREAM cream
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- NDC Code(s): 0363-0641-09, 0363-0641-10
- Packager: Walgreens
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 December 19, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
-
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
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding
- Keep out of reach of children.
-
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 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. Lubrcate 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.
-
Directions
Apply externally or in the lower portion of the anal canal only. Apply 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. Lubrcate dispensing cap well, then gently insert dispensing cap partway into the anus.
- Other information
- Inactive ingredients
- Carton label
- Tube label
-
INGREDIENTS AND APPEARANCE
HEMORRHOIDAL CREAM
hemorrhoidal cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0641 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 15 g in 100 g GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 14.4 g in 100 g PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 1 g in 100 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 0.25 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 37.45 g in 100 g POLYSORBATE 60 (UNII: CAL22UVI4M) 10 g in 100 g PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 4 g in 100 g STEARYL ALCOHOL (UNII: 2KR89I4H1Y) 3.3 g in 100 g GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 3.2 g in 100 g MINERAL OIL (UNII: T5L8T28FGP) 2 g in 100 g CETYL PALMITATE (UNII: 5ZA2S6B08X) 1 g in 100 g ALOE (UNII: V5VD430YW9) 1 g in 100 g SODIUM CITRATE (UNII: 1Q73Q2JULR) 1 g in 100 g ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.8 g in 100 g STEARIC ACID (UNII: 4ELV7Z65AP) 2 g in 100 g LANOLIN (UNII: 7EV65EAW6H) 0.5 g in 100 g METHYLPARABEN (UNII: A2I8C7HI9T) 0.2 g in 100 g PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.1 g in 100 g Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0641-09 1 in 1 PACKAGE 03/25/2018 1 NDC:0363-0641-10 25.5 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 not final part348 03/25/2018 Labeler - Walgreens (008965063) Establishment Name Address ID/FEI Business Operations Unipack 009248480 manufacture(0363-0641)
