HEMORRHOIDAL-OINTMENT- lidocaine 4.00, phenylephrine hydrochloride 0.25 ointment 
Rrhoid Rage

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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Rrhoid Rage hemorrhoidal Ointment

Lidocaine 4%..................................................Local Anesthetic

Phenylephrine Hydrochloride 0.25%...............Vasoconstrictor

Local anesthetic, Vasoconstrictor

-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.

For external and/or intrarectal 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.

-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).

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.

tube

HEMORRHOIDAL-OINTMENT 
lidocaine 4.00, phenylephrine hydrochloride 0.25 ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82433-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE0.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BALSAM FIR LEAFY TWIG (UNII: H1TFV1454Z)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
LANOLIN (UNII: 7EV65EAW6H)  
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
ALOE (UNII: V5VD430YW9)  
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
GLYCERIN (UNII: PDC6A3C0OX)  
WITCH HAZEL (UNII: 101I4J0U34)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82433-101-011 in 1 CARTON06/06/2022
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 finalpart34606/06/2022
Labeler - Rrhoid Rage (035330878)
Registrant - Rrhoid Rage (035330878)

Revised: 6/2022
Document Id: e0cb37bd-6dca-de9c-e053-2a95a90a3516
Set id: e0cb37bd-6dc9-de9c-e053-2a95a90a3516
Version: 1
Effective Time: 20220606
 
Rrhoid Rage