LONAZEM- menthol,petrolatum ointment

LONAZEM by

Drug Labeling and Warnings

LONAZEM by is a Otc medication manufactured, distributed, or labeled by PEER PHARM LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Menthol 0.1%
Petrolatum 80%

Purpose

Menthol…….Antipruritic
Petrolatum…..Protectant

Uses

• Helps relieve the itching and discomfort associated with hemorrhoids, inflamed hemorrhoidal tissues, anorectal disorders and anorectal inflammation
• Temporarily protects irritated areas
• Temporarily provides a coating for relief of anorectal discomforts
• Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
• Temporarily relieves the symptoms of perianal skin irritation
• Temporarily protects inflamed perianal skin
• For the temporary relief of pain or burning
• May provide a cooling sensation

Warnings

• For external and/or intrarectal use only
• When using this product

if condition worsens or does not improve within 7 days, consult a doctor

do not exceed the recommended daily dosage unless directed by a doctor

in case of bleeding, consult a doctor promptly

• Do not insert the applicator into the rectum if it causes additional pain. Consult a doctor promptly.

If Pregnant or Breastfeeding, ask a healthcare provider before using.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Directions

• adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by blotting or patting with a tissue or a soft cloth before applying ointment.
• Apply to the affected area up to 6 times daily, especially at night, in the morning or after ' each bowel movement.
• EXTERNAL USE: Apply to external anal area.
• INTRARECTAL USE: Lubricate applicator well with Lonazem ointment, then gently insert applicator into the rectum.
• Children under 12 years of age: consult a doctor

Inactive Ingredients

butyrospermum parkii (shea) butter, cetearyl alcohol, juniper berry volatile oil, origanum vulgare leaf extract, rosmarinus officinalis leaf extract, thymus vulgaris leaf extract, zea mays (corn) oil

Questions or comments?

Contact us at lonazem.com or at Dorrington LLC, 7 Skyline Dr., Suite 350, Hawthorne, NY 10532

Product label

INGREDIENTS AND APPEARANCE

LONAZEM 
menthol,petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69435-1200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.1 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	80 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
JUNIPER BERRY OIL (UNII: SZH16H44UY)
OREGANO (UNII: 0E5AT8T16U)
THYMUS VULGARIS LEAF (UNII: GRX3499643)
ROSEMARY (UNII: IJ67X351P9)
CORN OIL (UNII: 8470G57WFM)
SHEA BUTTER (UNII: K49155WL9Y)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69435-1200-1	10 in 1 CARTON	03/01/2024
1		3 g 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 Drug	M015	03/01/2024

Labeler - PEER PHARM LTD. (514678390)

Establishment
Name	Address	ID/FEI	Business Operations
PEER PHARM LTD.		514678390	manufacture(69435-1200)