REXALL HEMORRHOIDAL- glycerin, phenylephrine hydrochloride, pramoxine hydrochloride, and petrolatum cream 
Dolegencorp,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.

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Rexall® Hemorrhoidal Cream
Topical

Drug Facts

Active ingredientsPurposes
Glycerin 14.4%Protectant
Petrolatum 15%Protectant
Phenylephrine hydrochloride 0.25%Vasoconstrictor
Pramoxine hydrochloride 1%Local anesthetic

Uses

Warnings

For external use only.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty urinating due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are 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
  • do not put into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

  • bleeding occurs
  • the condition worsens or does not improve within 7 days
  • an allergic reaction develops
  • the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase

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

Adults:

Other information

Inactive ingredients

aloe barbadensis leaf juice, BHA, cetyl alcohol, citric acid, disodium EDTA, glyceryl stearate, laureth-23, mineral oil, panthenol, pheoxy ethenol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium carboxymethylcellulose, steareth-2, steareth-20, stearyl alcohol, tocopherol (vitamin E) acetate, xanthan gum

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

NDC 55910-331-24

Since 1903
Rexall®

MAXIMUM STRENGTH

Hemorrhoidal Cream

NET WT 1 OZ (28 g)

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
REXALL HEMORRHOIDAL 
glycerin, phenylephrine hydrochloride, pramoxine hydrochloride, and petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-331
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin0.144 mg  in 1 g
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride0.0025 mg  in 1 g
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine Hydrochloride0.1 mg  in 1 g
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum0.15 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Butylated Hydroxyanisole (UNII: REK4960K2U)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Edetate Disodium (UNII: 7FLD91C86K)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Laureth-23 (UNII: N72LMW566G)  
Mineral Oil (UNII: T5L8T28FGP)  
Panthenol (UNII: WV9CM0O67Z)  
Propyl Gallate (UNII: 8D4SNN7V92)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Steareth-2 (UNII: V56DFE46J5)  
Steareth-20 (UNII: L0Q8IK9E08)  
Stearyl Alcohol (UNII: 2KR89I4H1Y)  
Tocopherol (UNII: R0ZB2556P8)  
.Alpha.-Tocopherol (UNII: H4N855PNZ1)  
Water (UNII: 059QF0KO0R)  
Xanthan Gum (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-331-241 in 1 CARTON03/01/2014
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34603/01/2014
Labeler - Dolegencorp,LLC (068331990)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(55910-331)

Revised: 12/2022
Document Id: b359104b-8264-40e5-a01e-1eb79997c892
Set id: bf4b6237-90c3-415f-a5dd-e0f777bde60a
Version: 3
Effective Time: 20221206
 
Dolegencorp,LLC