LIDOFORTE HEMORRHOIDAL- lidocaine mineral phenylephrine hydrochloride petrolatum cream

lidoForte Hemorrhoidal by

Drug Labeling and Warnings

lidoForte Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by Satius Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredients

Lidocaine 5% w/w

Mineral Oil 17% w/w

Phenylephrine HCI 0.25% w/w

White Petrolatum 39% w/w

Purpose

Local anesthetic

Protectant

Vasoconstrictor

Protectant

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
• To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.

Other information

Store at 25 degrees C (77 Degrees F); excursions permitted to 15-30 degrees C (59-86 degrees F)
[see USP Controlled Room Temperature].

Inactive ingredients

Aqua (purified water), Benzyl Alcohol, Cetearyl Alcohol, Ceteareth-20, Citric Acid, Dehydroacetic Acid

Package Labeling:

INGREDIENTS AND APPEARANCE

LIDOFORTE HEMORRHOIDAL 
lidocaine mineral phenylephrine hydrochloride petrolatum cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71890-310
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 mg  in 1 mL
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	170 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	25 mg  in 1 mL
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	390 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71890-310-01	1 in 1 BOX	11/18/2017
1		44.3603 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	11/18/2017

Labeler - Satius Pharmaceuticals, LLC (080518631)