ER HEMORRHOID- phenylephrine hcl cream

ER Hemorrhoid by

Drug Labeling and Warnings

ER Hemorrhoid by is a Otc medication manufactured, distributed, or labeled by EVER READY FIRST AID, Nantong Health & Beyond Hygienic Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Mineral Oil                   14%
Petrolatum                   74.9% 
Phenylephrine HCI        0.25% 

Purpose

Protectant
Protectant
Vasoconstrictor

Uses

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

Warnings

For external use only.

ASK DOCTOR

Ask a doctor before use if you have

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

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before useif you are presently taking a prescription drug for high blood pressure or depression

WHEN USING

When using this productdo not exceed the recommended daily dosage unless directed by a doctor

STOP USE

Stop use and ask a doctor if

• bleeding occurs
• condition worsens or does not improve within 7 days
• introduction of applicator into the rectum causes additional pain

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a healthcare 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)

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 applying ointment
• when first opening the tube, puncture foil seal secured on tube
• apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
• intrarectal use:remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum
• thoroughly cleanse applicator after each use and replace cover also apply ointment to external area regular use provides continual therapy for relief of symptoms
• children under 12 years of age: ask a doctor

Other Information

• store at 20°-25°C (68°-77°F)
• do not use if tube seal under cap is broken

Inactive Ingredients

beeswax, ceteareth-20, cetostearyl alcohol, glycerin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ER HEMORRHOID 
phenylephrine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72976-018
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	0.14 g  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	0.749 g  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	0.0025 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72976-018-01	57 g in 1 TUBE; Type 0: Not a Combination Product	02/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	02/02/2024

Labeler - EVER READY FIRST AID (147372960)

Registrant - Nantong Health & Beyond Hygienic Products Inc. (421280161)

Establishment
Name	Address	ID/FEI	Business Operations
Nantong Health & Beyond Hygienic Products Inc.		421280161	manufacture(72976-018)