Label: HEMORRHOIDAL- mineral oil, petrolatum, phenylephrine hci ointment
- NDC Code(s): 63868-684-02
- Packager: Chain Drug Marketing Association Inc.
- Category: HUMAN OTC DRUG LABEL
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 May 23, 2023
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- Drug Facts
- Active Ingredient
- Purpose
- Active Ingredient
- Purpose
- Active Ingredient
- Purpose
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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
- Stop Use and Ask Doctor if
- If Pregnant or breast-feeding
- Keep out of reach of children
- Ask doctor before use
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Directions
- Adults and children 12 years of age and older for topical use:
- Clean the affected area and pat or dab dry before applying ointment.
- apply to the affected area up to 4 times daily, especially after each bowel movement.
- attach included applicator to tube
- lubricate applicator tip and gently insert into the rectum.
- thoroughly clean applicator after each use and replace cover.
- Children under 12 years of age; ask doctor before use
- Other Information
- Inactive Ingredients
- Questions or Comments?
- Distributed By
- Packaging
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INGREDIENTS AND APPEARANCE
HEMORRHOIDAL
mineral oil, petrolatum, phenylephrine hci ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-684 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 0.25 g in 100 g MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 14 g in 100 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 74.9 g in 100 g Inactive Ingredients Ingredient Name Strength STEARYL ALCOHOL (UNII: 2KR89I4H1Y) BENZOIC ACID (UNII: 8SKN0B0MIM) CETYL ALCOHOL (UNII: 936JST6JCN) LAURETH-23 (UNII: N72LMW566G) METHYLPARABEN (UNII: A2I8C7HI9T) YELLOW WAX (UNII: 2ZA36H0S2V) GLYCERIN (UNII: PDC6A3C0OX) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-684-02 1 in 1 BOX 08/14/2020 1 57 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 08/14/2020 Labeler - Chain Drug Marketing Association Inc. (011920774) Registrant - Trifecta Pharmaceuticals USA LLC (079424163)