HEMORRHOIDAL COCOA BUTTER- hemorrhoidal suppository 
NeilMed Pharmaceuticals Inc.

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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NeilMed Hemorrhoidal Suppositories 24count

Drug Facts :
Active Ingredients (in each suppository) :

Cocoa butter 88.44%

Phenylephrine Hydrochloride 0.25%

Purpose

Protectant

Vasoconstrictor

Uses:

• helps relieve the local itching and discomfort associated with hemorrhoids • temporarily relieves burning and shrinks hemorrhoidal tissue • temporarily provides a coating for relief of anorectal discomforts • temporarily protects the inflamed, irritatedanorectal surface to help make bowel movements less painful.

Warnings:

For rectal use only

Ask a doctor before use if you have

• heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of prostate gland unless directed by a doctor

Ask a doctor or pharmacist before use

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 the recommended daily dosage unless directed by a doctor
• children under 12 years of age: ask a doctor

Stop use and ask doctor if

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

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. (1-800-222-1222)

Other information:

store at 20° - 25°C (68° - 77°F)

Inactive ingredients:

methylparaben, propylparaben, topical starch

Directions:

• Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before insertion of this product. • detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows:

• hold suppository with rounded end • see illustrations; carefully separate foil tabs by inserting tip of fingernail at end marked “peel
down” • slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose the suppository • remove exposed
suppository from wrapper • insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each
bowel movement.

Shrinks Swollen Tissue
• Reduces internal swelling, soothes & protects
• Gives prompt relief from the painful burning, itching & discomfort from hemorrhoids on a temporary basis

Suppositories 24count

HEMORRHOIDAL COCOA BUTTER 
hemorrhoidal suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-323
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER884.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13709-323-014 in 1 CARTON08/24/2023
16 in 1 BLISTER PACK
12 g in 1 CAPSULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01508/24/2023
Labeler - NeilMed Pharmaceuticals Inc. (799295915)
Establishment
NameAddressID/FEIBusiness Operations
NeilMed Pharmaceuticals Inc.799295915manufacture(13709-323)

Revised: 8/2023
Document Id: 03b159b0-b961-b38d-e063-6394a90a9462
Set id: 03b159b0-b960-b38d-e063-6394a90a9462
Version: 1
Effective Time: 20230824
 
NeilMed Pharmaceuticals Inc.