Label: HEMORRHOIDAL- mineral oil, petrolatum, phenylephrine hcl ointment
- NDC Code(s): 69452-448-38
- Packager: Bionpharma Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 31, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
-
Uses
■ Helps relieve the local itching and discomfort associated with hemorrhoids
■ Temporarily shrinks hemorrhoidal tissue and relieves burning
■ 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
- 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 pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying ointment.
■ Apply to affected areas up to 4 times daily.
■ EXTERNAL USE: Apply to affected area
■ FOR INTRARECTAL USE: ■ Remove cover from the applicator ■ Attach applicator to tube ■ Lubricate applicator well, then gently insert applicator into the rectum ■ Thoroughly clean applicator after each use and replace cover
■ Children under 12 years of age: consult a doctor - Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
-
tube carton
*compare to the active ingredient in Preparation H ® Hemorrhoid Treatment Ointment
NDC 69452-448-38
a+ health TM
hemorrhoidal ointment
• reduces irritation • with applicator
dye-free • phthalate-free • fragrance-free
• relieves both internal and external hemorrhoid symptoms
• temporarily shrinks swollen hemorrhoidal tissue
• prompt, soothing relief from painful burning, itching and discomfortnet wt. 2 oz

-
INGREDIENTS AND APPEARANCE
HEMORRHOIDAL
mineral oil, petrolatum, phenylephrine hcl ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69452-448 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 749 mg in 1 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 2.5 mg in 1 g MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 140 mg in 1 g Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WHITE WAX (UNII: 7G1J5DA97F) BENZOIC ACID (UNII: 8SKN0B0MIM) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) CORN OIL (UNII: 8470G57WFM) LANOLIN (UNII: 7EV65EAW6H) GLYCERIN (UNII: PDC6A3C0OX) LANOLIN ALCOHOLS (UNII: 884C3FA9HE) METHYLPARABEN (UNII: A2I8C7HI9T) WATER (UNII: 059QF0KO0R) PARAFFIN (UNII: I9O0E3H2ZE) PROPYLPARABEN (UNII: Z8IX2SC1OH) THYME OIL (UNII: 2UK410MY6B) Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69452-448-38 1 in 1 CARTON 04/10/2025 1 56 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 Drug M015 04/10/2025 Labeler - Bionpharma Inc. (079637826) Registrant - Bionpharma Inc. (079637826) Establishment Name Address ID/FEI Business Operations Galentic Pharma (India) Private Limited 650970176 manufacture(69452-448)
