Label: REXALL HEMORRHOIDAL COOLING GEL- witch hazel and phenylephrine hydrochloride cream
- NDC Code(s): 55910-332-24
- Packager: DOLGENCORP, LLC
- 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 December 6, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- temporarily relieves anorectal itching and discomfort associated with hemorrhoids or anorectal disorders
- temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders
- temporarily shrinks hemorrhoidal tissue
- aids in protecting irritated anorectal areas
- temporary relief of burning
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Warnings
For external 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
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Adults
- when practical, cleanse affected area by patting or blotting with appropriate cleansing wipe. Gently dry by patting or blotting with tissue or soft cloth before applying gel
- apply externally to affected area up to 4 times daily or after each bowel movement
- Children under 12 years old: Ask a doctor.
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Adults
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL - 26 g Tube Carton
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INGREDIENTS AND APPEARANCE
REXALL HEMORRHOIDAL COOLING GEL
witch hazel and phenylephrine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-332 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Witch Hazel (UNII: 101I4J0U34) (Witch Hazel - UNII:101I4J0U34) Witch Hazel 0.5 mg in 1 g Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 0.0025 mg in 1 g Inactive Ingredients Ingredient Name Strength Aloe Vera Leaf (UNII: ZY81Z83H0X) Benzophenone (UNII: 701M4TTV9O) Edetate Disodium (UNII: 7FLD91C86K) Hydroxyethyl Cellulose (280 Mpa.S At 2%) (UNII: 12VCE9HR9E) Propylene Glycol (UNII: 6DC9Q167V3) Water (UNII: 059QF0KO0R) Anhydrous Trisodium Citrate (UNII: RS7A450LGA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-332-24 1 in 1 CARTON 03/18/2014 1 26 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 03/18/2014 Labeler - DOLGENCORP, LLC (068331990) Establishment Name Address ID/FEI Business Operations Natureplex LLC 062808196 MANUFACTURE(55910-332)