HEMORRHOIDAL- cocoa butter, phenylephrine hydrochloride suppository 
GRAXCELL PHARMACEUTICAL, 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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HEMORRHOIDAL SUPPOSITORIES, 70795-1021

Active Ingredients (per suppository)

Cocoa butter 88.44 %

Phenylephrine hydrochloride 0.25 %

Purpose

Protectant

Vasoconstructor

Uses

Warnings

For rectal use only

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug for high blood pressure or depression

Ask a doctor before use if you have

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

When using this product

  • do not exceed the recommended daily dosage unless directed by a doctor
  • in case of bleeding or if condition worsens or does not improve within 7 days, consult a doctor promptly

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.

Directions Adults

Other Information

Store at room temperature or in a cool place but not over 80° F

Inactive ingredients

methylparaben, propylparaben, starch

Label 1

Label 2

HEMORRHOIDAL 
cocoa butter, phenylephrine hydrochloride suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70795-1021
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER1768.8 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STARCH, CORN (UNII: O8232NY3SJ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70795-1021-212 in 1 BOX03/29/2017
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:70795-1021-424 in 1 BOX04/22/2017
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/29/2017
Labeler - GRAXCELL PHARMACEUTICAL, LLC (056556923)
Registrant - GRAXCELL PHARMACEUTICAL, LLC. (056556923)

Revised: 12/2021
Document Id: d3aed0a8-899f-525c-e053-2995a90a7d37
Set id: 5162baee-0d63-494e-8046-459437b85348
Version: 7
Effective Time: 20211221
 
GRAXCELL PHARMACEUTICAL, LLC