RRHOID RAGE HEMORRHOIDAL- lidocaine, phenylephrine hydrochloride ointment 
POPPY COLLECTIVE LLC

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RRHOID RAGE Hemorrhoidal Ointment

Drug Facts

Active Ingredients

Lidocaine 4%

Phenylephrine HCL 0.25%

Purpose

Local Anesthetic

Vasoconstrictor

Uses

–Helps relieve the pain, itching, and burning associated with hemorrhoids.

–Temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders.

–Temporarily provides a coating for relief of anorectal discomforts.

–Temporarily protects irritated areas and inflamed perianal skin.

Warnings

For external 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 the prostate gland.

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

–Avoid contact with eyes.

–Do not exceed recommended daily dosage unless directed by a doctor.

–Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if

–Bleeding occurs.

–Condition worsens or does not improve within 7 days.

–Allergic reaction occurs to ingredients in this product.

–Symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.

If pregnant or breastfeeding,

ask a doctor before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

–When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.

–Adults and children 12 years and older: apply externally to the affected area up to 4 times daily.

–Children under 12 years of age: consult a doctor.

Other information

–Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F).

Inactive ingredients

aloe extract AQ, balsam fir, butylated hydroxyanisol, glycerin, lanolin alcohols, lanolin USP, magnesium sulfate, methyl paraben, mineral oil, petrolatum, propylparaben, witch hazel, white bees wax.

Package Labeling:

Label

RRHOID RAGE HEMORRHOIDAL 
lidocaine, phenylephrine hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82433-446
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
GLYCERIN (UNII: PDC6A3C0OX)  
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WITCH HAZEL (UNII: 101I4J0U34)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82433-446-001 in 1 BOX02/12/2024
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 DrugM01502/12/2024
Labeler - POPPY COLLECTIVE LLC (035330878)

Revised: 1/2024
Document Id: 103c47fa-17f7-6e9b-e063-6294a90adce8
Set id: a02a6398-0acd-4aa7-8320-ac586ff12eb3
Version: 1
Effective Time: 20240131
 
POPPY COLLECTIVE LLC