Label: CAREALL HEMORRHOIDAL- mineral oil, petrolatum, phenylephrine hcl ointment
- NDC Code(s): 51824-079-02
- Packager: New World Imports, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 19, 2023
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Keep Out of Reach of Children
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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
For external and/or intrarectal use only
Ask a doctor before use if you have
▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes
▪ difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression
When using this product do not exceed the recommended daily dosage unless directed by a doctor
Stop use and ask a doctor if
▪ bleeding occurs ▪ condition worsens or does not improved within 7 days
▪ introduction of applicator into the rectum causes additional pain
If pregnant or breast-feeding, ask a health professional before use. -
Directions
Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toliet tissue or a soft cloth before applying ointment
- INTRARECTAL USE: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum, thoroughly cleanse applicator after each use and replace cover
- EXTERNAL USE: apply to affected area
- Apply to affected areas up to 4 times daily
Children under 12 years of age: consult a doctor
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CAREALL HEMORRHOIDAL
mineral oil, petrolatum, phenylephrine hcl ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-079 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 140 mg in 1 g 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 Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) CORN OIL (UNII: 8470G57WFM) GLYCERIN (UNII: PDC6A3C0OX) LANOLIN (UNII: 7EV65EAW6H) LANOLIN ALCOHOLS (UNII: 884C3FA9HE) METHYLPARABEN (UNII: A2I8C7HI9T) PARAFFIN (UNII: I9O0E3H2ZE) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) THYME OIL (UNII: 2UK410MY6B) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WHITE WAX (UNII: 7G1J5DA97F) Product Characteristics Color yellow (Light Yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51824-079-02 56 g in 1 TUBE; Type 0: Not a Combination Product 01/02/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M015 01/01/2020 Labeler - New World Imports, Inc (075372276)