Label: HEB HEMORRHOIDAL- mineral oil, petrolatum, and phenylephrine hydrochloride cream
- NDC Code(s): 37808-991-24
- Packager: H-E-B
- 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.
Drug Label Information
Updated October 25, 2018
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- For the temporary relief of anorectal itching and discomfort associated with hemorrhoids.
- Temporarily reduces swelling associated with irritation in hemorrhoids and other anorectal disorders
- Temporarily shrinks hemorrhoidal tissue
- Temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues
- Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
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Warnings
For external and/or intrarectal use only
Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
Ask a doctor or pharmacist before use if you are
- presently taking a prescription drug for high blood pressure or depression.
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Directions
- Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with a tissue or a soft cloth before application of this product
- apply externally to the affected area up to 4 times daily
- 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
- Children under 12 years of age: consult a physician
- Other information
- Inactive ingredients
- Questions or comments?
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PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton
Compare to Preperation H® Ointment active ingredients*
H-E-B ®
NDC 37808-991-24
Hemorrhoidal Ointment
Mineral Oil / Petrolatum / Protectant
Phenylephrine Hydrochloride / VasoconstrictorIncludes
Dispensing
CapHemorrhoid Symptom Relief
- Helps Relieve Pain & Itching
- Lubricating Coating Protects Irritated Tissue
NET WT 2.0 OZ (56.7 g)
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INGREDIENTS AND APPEARANCE
HEB HEMORRHOIDAL
mineral oil, petrolatum, and phenylephrine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-991 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 0.25 g in 100 g Inactive Ingredients Ingredient Name Strength Benzoic Acid (UNII: 8SKN0B0MIM) White Wax (UNII: 7G1J5DA97F) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37808-991-24 1 in 1 CARTON 10/23/2018 1 56.7 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 10/23/2018 Labeler - H-E-B (007924756) Establishment Name Address ID/FEI Business Operations Natureplex LLC 062808196 MANUFACTURE(37808-991)