REXALL HEMORRHOIDAL COOLING GEL- witch hazel and phenylephrine hydrochloride cream 
DOLGENCORP, LLC

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.

----------

Rexall® Hemorrhoidal Cooling Gel
Topical

Drug Facts

Active ingredientsPurposes
Hamamelis virginiana (witch hazel) 50%Astringent
Phenylephrine hydrochloride 0.25%Vasoconstrictor

Uses

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

When using this product

  • do not exceed recommended daily dosage unless directed by a doctor
  • do not put into rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

  • condition worsens or does not improve within 7 days
  • bleeding occurs

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

Other information

Inactive ingredients

aloe barbadensis leaf juice, benzophenone-4, disodium EDTA, hydroxyethylcellulose, phenoxy ethenol, propylene glycol, purified water, sodium benzoate, sodium citrate

PRINCIPAL DISPLAY PANEL - 26 g Tube Carton

NDC 55910-332-24

Since 1903
Rexall®

CLEAR, NON-GREASY FORMULA

Hemorrhoidal Cooling Gel

Enriched
with
Aloe

NET WT 0.9 OZ (26 g)

PRINCIPAL DISPLAY PANEL - 26 g Tube Carton
REXALL HEMORRHOIDAL COOLING GEL 
witch hazel and phenylephrine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-332
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Witch Hazel (UNII: 101I4J0U34) (Witch Hazel - UNII:101I4J0U34) Witch Hazel0.5 mg  in 1 g
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride0.0025 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-332-241 in 1 CARTON03/18/2014
126 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Finalpart34603/18/2014
Labeler - DOLGENCORP, LLC (068331990)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(55910-332)

Revised: 12/2022
Document Id: 9a97910f-603a-4076-9f40-52d48160a526
Set id: cf6414f3-c1ef-49cf-8ebe-09192db6dd07
Version: 3
Effective Time: 20221206
 
DOLGENCORP, LLC